Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-16 @ 9:05 AM
Study NCT ID:
NCT02887404
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2016-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Spine Surgery Analgesic Pathway
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maheshk@ccf.org', 'phone': '216-4454311', 'title': 'Dr. Kamal Maheshwari', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'within 3 months since the onset of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'spread': '25', 'groupId': 'OG000'}, {'value': '109', 'spread': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-6', 'ciUpperLimit': '6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Three days after surgery', 'description': 'Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '21 patients in the treatment group were missing and 20 patients were missing in the placebo group'}, {'type': 'SECONDARY', 'title': 'Opioid Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '113'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '152'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-21', 'ciUpperLimit': '3', 'statisticalMethod': 'Hodges-Lehmann estimator', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Delta: 15. The significance level for non-inferiority was 0.025'}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-9', 'ciLowerLimit': '-23', 'ciUpperLimit': '5', 'pValueComment': 'We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.', 'statisticalMethod': 'Hodges-Lehmann estimator', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 48 hours', 'description': 'Opioid consumption within the initial 48 h was converted to IV morphine equivalents using the conversions specified in Supplemental Digital Content 1 (http:// links.lww.com/ALN/C178).', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time-weighted Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1', 'pValueComment': 'This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Delta: 1 The significance level for the non-inferiority test was 0.025.'}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'pValueComment': 'We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '15-min interval after surgery until postoperative 2 days or discharge, whichever came first', 'description': 'Postoperative pain was evaluated with numeric rating scores (0-10) at 15-min intervals for the initial two postoperative hours or until discharge, whichever came first. A time-weighted averages pain score is equal to the sum of the portion of each time interval (as a decimal, such as 0.25h) multiplied by the levels of the pain (0-10 numeric rating scores) during the time period divided by 48h.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid-related Side Effects Score POD1 (Postoperative Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'POD1', 'description': 'Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid-related Side Effects Score POD2 (Postoperative Day 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'POD2', 'description': 'Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '22', 'groupId': 'OG000'}, {'value': '81', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'POD 3 (72 hours) or discharge, whichever comes earlier', 'description': 'The patient satisfaction with pain management at discharge using (NRS 1-100) or on POD 3 or discharge, whichever comes earlier. The higher score means a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '22', 'groupId': 'OG000'}, {'value': '122', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 months', 'description': 'Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory to Measure PDQ (Pain Disability) Using EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 months', 'description': 'Using EQ-5D questionnaire for pain disability measurements, at 3 months with the flexibility of +/- 5 days using the EQ-5D questionnaire (0) no pain to (10) worst pain. EQ-5D is a standardized measure of health status developed by EuroQol GROUP', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory to Measure Health-related Quality of Life Using EQ-5D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'It is one of several instruments used to verify the quality-adjusted life years associated with a health state. It is defined as a survey instrument for measuring economic preferences for health states based on the assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 items in total). Each dimension has 3 levels: 1=no problem, 2=moderate problem, 3=severe problem. The total scores are calculated for each subject.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 3 months', 'description': 'The exploratory outcome chronic postsurgical pain at 3 months was assessed by phone call using a numeric rating scale (0 to 10) where a score of 0 is "no pain" and a score of 10 is "pain as bad as it could be."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: PACU Length of Stay (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '5.0'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from the time when patients were transferred to the Post-Anesthesia Care Unit to the time when patients were transferred out from the Post-Anesthesia Care Unit.', 'description': 'Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'postoperative time until discharge', 'description': 'Postoperative nausea and vomiting was assessed using Postoperative Nursing Progress Record (NPR) - Records nausea vomiting severity as 0=none, 1= mild, 2=moderate, 3= severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Postoperative Length of Hospital Stay (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'postoperative time until discharge', 'description': 'Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'postoperative until discharge', 'description': 'The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: Number of Participants With Postoperative Acetaminophen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after surgery', 'description': 'This outcome measured how many patients used acetaminophen during the 48 hours after the surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: the Number of Patients Who Had Postoperative Gabapentin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after surgery', 'description': 'This outcome measured how many patients used postoperative gabapentin during the 48 hours after the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: the Number of Patients Who Had Postoperative Tramadol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours after surgery', 'description': 'This outcome measured how many patients used postoperative tramadol during the 48 hours after the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: the Number of Patients Who Had Postoperative Ketorolac Within 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 48 hours after surgery', 'description': 'This outcome measured how many patients used postoperative ketorolac during the 48 hours after the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: the Number of Patients Who Had Postoperative Suboxone Within 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 48 hours after surgery', 'description': 'This outcome measured how many patients used postoperative suboxone during the 48 hours after the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Exploratory Outcome: the Number of Patients Who Had Postoperative PCA (Patient-controlled Analgesia) Use Within 48h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 48 hours after surgery', 'description': 'This outcome measured how many patients used postoperative patient-controlled analgesia during the 48 hours after the surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Secondary Outcome: 24-h Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '68'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '81'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Delta: 9; significance level was 0.025'}, {'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'pValueComment': 'We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice', 'statisticalMethod': 'Wilcoxon sum rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'within 24 hours after the surgery', 'description': 'This outcome measured how many postoperative opioids (mg in morphine equivalents) patients used during the 24 hours after the surgery.', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Secondary Outcome: 24h Time-weighted Average Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Delta: 1 significance level: 0.025', 'otherAnalysisDescription': 'The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.'}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'pValueComment': 'We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'within 24 hours after the surgery', 'description': 'Pain score is a 10 point scale score where the higher means more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Spine Surgery Analgesic Pathway', 'description': 'Before surgery, the subject will be given one-time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery, the subject will receive an infusion of ketamine (5 ug/kg/min; Ketamine was stopped at wound closure.) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nSpine surgery analgesic pathway: Enhanced pain management care'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.\n\nUsual Care: Standard of pain management care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '12', 'groupId': 'BG000'}, {'value': '63', 'spread': '11', 'groupId': 'BG001'}, {'value': '63', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '7', 'groupId': 'BG000'}, {'value': '32', 'spread': '7', 'groupId': 'BG001'}, {'value': '31', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of chronic pain', 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous opioid use', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'High anxiety before surgery', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative pain score', 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The preoperative pain score rages from 0-10 where 0 means no pain and 10 means the worst pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA status, No (%)', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "ASA: American Society of Anesthesiologists Classification (ASA Class), which assesses a patient's overall health.\n\nI refer to ASA1-2 and II refer to ASA3 and III refer to ASA4-5.\n\nASA1: Patient is a completely healthy fit patient.\n\nASA2: Patient has mild systemic disease.\n\nASA3: Patient has severe systemic disease that is not incapacitating.\n\nASA4: Patient has incapacitating disease that is a constant threat to life.\n\nASA5: A moribund patient who is not expected to live 24 hour with or without surgery.", 'unitOfMeasure': 'Participants'}, {'title': 'Charlson comorbidity index, No(%)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '4 and above', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Charlson comorbidity index is a risk score assigned to patients for assessing their one-year mortality risk. It is based on a weighted count of specific chronic conditions in a patient's diagnosis history. Higher scores mean higher risk. Generally 0-2 means low risk; 3-4 means moderate risk and above 5 means high risk.", 'unitOfMeasure': 'Participants'}, {'title': 'No. of risk factors for uncontrolled postoperative pain', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The risk factors for uncontrolled postoperative pain were defined in the protocol and included young age (60 yr old and younger), female sex, chronic pain for more than 3 months, high preoperative pain score (VAS scale ≥7), preoperative high anxiety level, and multilevel surgery.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 807913, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-06T16:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2016-08-17', 'resultsFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-15', 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcome Measurement Patient Satisfaction With Pain Management at Discharge From the Hospital (Numeric Rating System 1-100)', 'timeFrame': 'POD 3 (72 hours) or discharge, whichever comes earlier', 'description': 'The patient satisfaction with pain management at discharge using (NRS 1-100) or on POD 3 or discharge, whichever comes earlier. The higher score means a better outcome'}, {'measure': 'Exploratory Outcome Measurement Quality of Recovery (QoR) Score at 1 Months', 'timeFrame': 'At 1 months', 'description': 'Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.'}, {'measure': 'Exploratory to Measure PDQ (Pain Disability) Using EQ-5D', 'timeFrame': 'Up to 3 months', 'description': 'Using EQ-5D questionnaire for pain disability measurements, at 3 months with the flexibility of +/- 5 days using the EQ-5D questionnaire (0) no pain to (10) worst pain. EQ-5D is a standardized measure of health status developed by EuroQol GROUP'}, {'measure': 'Exploratory to Measure Health-related Quality of Life Using EQ-5D', 'timeFrame': 'baseline', 'description': 'It is one of several instruments used to verify the quality-adjusted life years associated with a health state. It is defined as a survey instrument for measuring economic preferences for health states based on the assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression (5 items in total). Each dimension has 3 levels: 1=no problem, 2=moderate problem, 3=severe problem. The total scores are calculated for each subject.'}, {'measure': 'Exploratory Outcome: Chronic Postsurgical Pain at 3 Months (0-10 NRS Scale)', 'timeFrame': 'at 3 months', 'description': 'The exploratory outcome chronic postsurgical pain at 3 months was assessed by phone call using a numeric rating scale (0 to 10) where a score of 0 is "no pain" and a score of 10 is "pain as bad as it could be."'}, {'measure': 'Exploratory Outcome: PACU Length of Stay (h)', 'timeFrame': 'from the time when patients were transferred to the Post-Anesthesia Care Unit to the time when patients were transferred out from the Post-Anesthesia Care Unit.', 'description': 'Postoperative-anesthesia care unit (PACU) length of stay measured how many hours the patient had spent in PACU.'}, {'measure': 'Exploratory Outcome: Number of Patients Who Had Postoperative Nausea and Vomiting in PACU', 'timeFrame': 'postoperative time until discharge', 'description': 'Postoperative nausea and vomiting was assessed using Postoperative Nursing Progress Record (NPR) - Records nausea vomiting severity as 0=none, 1= mild, 2=moderate, 3= severe.'}, {'measure': 'Exploratory Outcome: Postoperative Length of Hospital Stay (Days)', 'timeFrame': 'postoperative time until discharge', 'description': 'Postoperative length of hospital stay measured how many days the patient had spent in the hospital after surgery.'}, {'measure': 'Exploratory Outcome: Need for Acute Pain Consultation, as Determined by Clinical Need', 'timeFrame': 'postoperative until discharge', 'description': 'The outcome measured how many patients needed acute pain consultation after the surgery, as determined by clinical need'}], 'primaryOutcomes': [{'measure': 'Quality of Recovery', 'timeFrame': 'Three days after surgery', 'description': 'Assessment of postoperative recovery should be multidimensional including physiological parameters, functional recovery parameters, and patient-reported outcomes. Quality of postoperative recovery will be assessed by asking the patient "how have you been feeling during the past 24 hours." Using the Quality of recovery form (QoR15) to document their replies. Quality of recovery (QoR15) score of (0 to 10), where: (0) none of the time (poor) and (10) equal all of the time (excellent). There are a total of 15 questions with each score ranging from 0 to 10. The range of reported total score is 0-150 where higher scores mean better quality of recovery.'}], 'secondaryOutcomes': [{'measure': 'Opioid Utilization', 'timeFrame': 'up to 48 hours', 'description': 'Opioid consumption within the initial 48 h was converted to IV morphine equivalents using the conversions specified in Supplemental Digital Content 1 (http:// links.lww.com/ALN/C178).'}, {'measure': 'Time-weighted Pain Score', 'timeFrame': '15-min interval after surgery until postoperative 2 days or discharge, whichever came first', 'description': 'Postoperative pain was evaluated with numeric rating scores (0-10) at 15-min intervals for the initial two postoperative hours or until discharge, whichever came first. A time-weighted averages pain score is equal to the sum of the portion of each time interval (as a decimal, such as 0.25h) multiplied by the levels of the pain (0-10 numeric rating scores) during the time period divided by 48h.'}, {'measure': 'Opioid-related Side Effects Score POD1 (Postoperative Day 1)', 'timeFrame': 'POD1', 'description': 'Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.'}, {'measure': 'Opioid-related Side Effects Score POD2 (Postoperative Day 2)', 'timeFrame': 'POD2', 'description': 'Opioid-Related Symptom Distress Scale (ORSDS) evaluates opioid-related side effects. ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 opioid-related side effects. The mean of the 12 scores are reported with a range from 0-4 where the higher scores mean more opioid-related side effects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Posterior Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery', 'detailedDescription': 'This is a randomized controlled trial comparing "spine surgery analgesic pathway" with "usual care" in improving postoperative quality of recovery and pain management in spine surgery patients. At the time of surgery office visit or at the time of preoperative assessment by anesthesia care team, risk factor for suboptimal pain management will be identified and documented. Patients will be assessed at the time for surgical office visit for their risk for severe post-operative pain. Patients with 2 or more risk factors will be classified as high-risk for severe postoperative pain and the patients with less than 2 factors as low risk. After obtaining informed consent spine surgery patients will be randomized 1:1 in one of the 2 study groups on the day of the surgery:\n\n1. "Usual care" group A\n2. "Care pathway" group B\n\nIf the participant is randomized to the "spine surgery analgesic pathway" group the participant will be evaluated by the Acute Pain Management Service (APMS) before the surgery for their specific pain management needs. The participant will also get some additional medication for pain in preoperative and intraoperative period. Before surgery the participant will receive Acetaminophen and Gabapentin pills. During the surgery, once the participant is asleep the participant will receive an infusion of ketamine and lidocaine through the participant venous line. After the surgery the participant will receive pain medications as per current standard protocol including acetaminophen and gabapentin. Pain management team specialist will follow for pain control after a surgery as needed.\n\nIf the participant is randomized to the "usual care" group the participant will be given placebo preoperatively; the rest of the time pain medication will be provided in a routine manner as per the anesthesia care team and the surgical team. Pain management team specialist will follow for pain control after a surgery as needed.\n\nThe primary outcome will be assessed on post-operative day 3: The participants will complete a short survey about quality of recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years old at time of surgery - Adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patients.\n* Posterior spine surgery\n* Surgery performed at Cleveland Clinic main campus\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to lidocaine, ketamine, acetaminophen, gabapentin\n* Current or recent drug abuse (within past 6 months)\n* Pregnancy\n* Immune system disease such as HIV, AIDS\n* Undergoing immunosuppressive treatment\n* Recent history of sepsis\n* Contraindications to lidocaine such as heart block and hepatic insufficiency\n* Heart failure with ejection fraction less than 30%\n* Liver dysfunction manifested with increased liver enzymes to double the normal and INR of 2 or higher'}, 'identificationModule': {'nctId': 'NCT02887404', 'briefTitle': 'Evaluation of Spine Surgery Analgesic Pathway', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Evaluation of Spine Surgery Analgesic Pathway: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '16-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spine surgery analgesic pathway', 'description': 'Before surgery the subject will be given one time oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nDuring surgery the subject will receive an infusion of ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start before the incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.', 'interventionNames': ['Other: Spine surgery analgesic pathway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Placebo- Before surgery the subject will be given one time placebo oral dose Acetaminophen (1000 mg ) and gabapentin (600 mg).\n\nPlacebo- During surgery the subject will receive a placebo infusion of - ketamine (5 mcg/kg/min) and lidocaine (1.5 mg/kg/hr start at incision and decreased to 1 mg/kg/hr at start of closing and continued to PACU and stop at the first oral intake).\n\nAfter surgery, the surgical team will manage pain medication and will consult acute pain management team as needed.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Spine surgery analgesic pathway', 'type': 'OTHER', 'description': 'Enhanced pain management care', 'armGroupLabels': ['Spine surgery analgesic pathway']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Standard of pain management care', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel I Sessler, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department Chair'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kamal Maheshwari, MD MPH', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}