Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 3:57 AM
Study NCT ID:
NCT02604550
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2015-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anterior Cruciate Ligament Pain Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jxeroge@emory.edu', 'phone': '404-778-7202', 'title': 'John Xerogeanes, MD', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data collection with a paper journal was low, resulting in the study switching to a smartphone application for participant record keeping. The data analyses include participants who enrolled after the smartphone application became available.'}}, 'adverseEventsModule': {'timeFrame': 'Data regarding adverse events were collected from the time a participant gave informed consent to take part in the study until the end of the study follow up.', 'description': 'Any change from baseline considered by the investigator to be an untoward medical occurrence different from the standard of care, was reported as an adverse event. Any change from baseline considered by the investigator to be part of the normal daily fluctuations of the underlying disease process, was not reported as an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'title': 'Recovery room discharge', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Day of surgery, evening', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 1 - Morning', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 1 - Afternoon', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 1 - Evening', 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 2 - Morning', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 2 - Afternoon', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 2 - Evening', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 3 - Morning', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 3 - Afternoon', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 3 - Evening', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 4 - Morning', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 4 - Afternoon', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 4 - Evening', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 5 - Morning', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 5 - Afternoon', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 5 - Evening', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 6 - Morning', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 6 - Afternoon', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 6 - Evening', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-surgery (day of surgery to 6 days post-surgery)', 'description': 'Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.'}, {'type': 'SECONDARY', 'title': 'Number of Percocet Tablets Consumed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'title': 'Day of surgery (Day 0)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 1', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 2', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 3', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 4', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 5', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Post-surgery Day 6', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post surgery, Day 0 to Day 6', 'description': 'Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,', 'unitOfMeasure': 'count of tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application to record the number of Percocet tablets taken for 6 days post-surgery.'}, {'type': 'SECONDARY', 'title': 'Total Hours of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First Postoperative Night (up to 12 hours)', 'description': 'The total hours of sleep first postoperative night, between 0 to 12 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application to record their number of hours of sleep during the night following their surgery.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported nausea post-surgery.', 'unitOfMeasure': 'occurrence of nausea', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported vomiting post-surgery.', 'unitOfMeasure': 'occurrence of vomiting', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced vomiting.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported constipation post-surgery.', 'unitOfMeasure': 'occurrence of constipation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants completing the study and who used a smartphone application for 6 days post-operatively to record every time they experienced constipation.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported feelings of sedation post-surgery.', 'unitOfMeasure': 'occurrence of sedation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced feelings of sedation.'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported itching post-surgery.', 'unitOfMeasure': 'occurrence of itching', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced itching.'}, {'type': 'SECONDARY', 'title': 'Time to Straight Less Raise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application to record when they were able to perform a straight leg raise following surgery.'}, {'type': 'SECONDARY', 'title': 'Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'OG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 Weeks Post-Surgery', 'description': 'Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'FG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incomplete data using paper journal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center in Atlanta, Georgia were prospectively randomized to receive either a femoral nerve block (FNB) or an adductor canal block (ACB). Participants were enrolled between December 2015 and April 2016.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Femoral Nerve Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.'}, {'id': 'BG001', 'title': 'Adductor Canal Block', 'description': 'Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who consented to take part in the trial and received the intervention of the study arm they were randomized to.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2015-11-11', 'resultsFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2015-11-11', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-21', 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Post-surgery (day of surgery to 6 days post-surgery)', 'description': 'Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.'}], 'secondaryOutcomes': [{'measure': 'Number of Percocet Tablets Consumed', 'timeFrame': 'Post surgery, Day 0 to Day 6', 'description': 'Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,'}, {'measure': 'Total Hours of Sleep', 'timeFrame': 'First Postoperative Night (up to 12 hours)', 'description': 'The total hours of sleep first postoperative night, between 0 to 12 hours.'}, {'measure': 'Patient-Reported Nausea', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported nausea post-surgery.'}, {'measure': 'Patient-Reported Vomiting', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported vomiting post-surgery.'}, {'measure': 'Patient-Reported Constipation', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported constipation post-surgery.'}, {'measure': 'Patient-Reported Sedation', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported feelings of sedation post-surgery.'}, {'measure': 'Patient-Reported Itching', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'Total occurrences of patient-reported itching post-surgery.'}, {'measure': 'Time to Straight Less Raise', 'timeFrame': 'Post-Surgery (up to 6 days)', 'description': 'The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.'}, {'measure': 'Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"', 'timeFrame': '2 Weeks Post-Surgery', 'description': 'Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.', 'detailedDescription': 'This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.\n\nThe objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center\n* Patients willing and able to provide written informed consent\n* Parents willing and able to provide written informed consent for minors\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating\n* Patients with liver dysfunction or renal failure\n* Patients with a known allergy to ropivacaine\n* Patients with a local infection\n* Patients who take chronic pain medications\n* Patients with an opioid tolerance\n* Patients with known coagulopathy or bleeding risk.\n* Patients who are getting neuraxial anesthesia for surgery'}, 'identificationModule': {'nctId': 'NCT02604550', 'briefTitle': 'Anterior Cruciate Ligament Pain Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00083740'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral Nerve Block', 'description': 'Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.', 'interventionNames': ['Drug: Ropivacaine 0.5%', 'Drug: Percocet 7.5/325', 'Drug: Naprosyn 500 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor Canal Block', 'description': 'Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.', 'interventionNames': ['Drug: Ropivacaine 0.5%', 'Drug: Percocet 7.5/325', 'Drug: Naprosyn 500 mg']}], 'interventions': [{'name': 'Ropivacaine 0.5%', 'type': 'DRUG', 'description': 'Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.', 'armGroupLabels': ['Adductor Canal Block', 'Femoral Nerve Block']}, {'name': 'Percocet 7.5/325', 'type': 'DRUG', 'description': 'Percocet 7.5/325 will taken as needed up to every four hours.', 'armGroupLabels': ['Adductor Canal Block', 'Femoral Nerve Block']}, {'name': 'Naprosyn 500 mg', 'type': 'DRUG', 'description': 'Naprosyn 500 mg will be taken twice daily.', 'armGroupLabels': ['Adductor Canal Block', 'Femoral Nerve Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Healthcare Orthopaedics and Spine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'John Xerogeanes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Xerogeanes', 'investigatorAffiliation': 'Emory University'}}}}