Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-15 @ 5:35 PM
Study NCT ID:
NCT03859635
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2019-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yyeap@iu.edu', 'phone': '3172740275', 'title': 'Yar Luan Yeap, MD', 'organization': 'Indiana University Department of Anesthesiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Any adverse events from day of surgery til 6 months after surgery are documented..', 'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Guided Loposomal Erector Spinae Block', 'description': 'Group 1-Ultrasound guided Liposomal Erector Spinae Block', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 1, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'Group-2-Ultrasound guided Standard Bupivacaine Erector Spinae Block', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Surgeon Infiltration', 'description': 'Group 3-Surgeon Infiltration', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numEvents': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'default'}, {'term': 'Respiratory Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numEvents': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'default'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours pain score at rest', 'description': 'The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours pain score with movement', 'description': 'The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours pain score at rest', 'description': 'The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Includes Total Opioid Consumption at 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '68'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '72'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements', 'unitOfMeasure': 'mg morphine equivalant/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}, {'type': 'SECONDARY', 'title': 'Average Nausea Scores Over 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged', 'description': 'Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as None=0, Mild=1, Moderate=2, Severe=3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}, {'type': 'SECONDARY', 'title': 'Average Sedation Scores Over 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]', 'description': 'Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Overall Satisfaction Scores at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post operatively at hour 24', 'description': 'Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Overall Satisfaction Scores at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post operatively at hour 48', 'description': 'Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Includes Total Opioid Consumption at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '88'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '76'}, {'value': '60', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements', 'unitOfMeasure': 'mg morphine equivalant/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Includes Total Opioid Consumption at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '62'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '96'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements', 'unitOfMeasure': 'mg morphine equivalant/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Includes Total Opioid Consumption at 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '20'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '20'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 1hr will be collected by a study team member per protocol time requirements', 'unitOfMeasure': 'mg morphine equivalant', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}, {'type': 'PRIMARY', 'title': 'The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'OG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'OG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours pain score with movement', 'description': 'The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'FG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'FG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'BG001', 'title': 'Ultrasound Guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nBupivacaine, 0.5%: 30 ml'}, {'id': 'BG002', 'title': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.\n\nLiposomal Bupivacaine: 20 ml\n\nBupivacaine, 0.25%: 10 ml'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '63', 'spread': '9', 'groupId': 'BG000'}, {'value': '64', 'spread': '10', 'groupId': 'BG001'}, {'value': '66', 'spread': '12', 'groupId': 'BG002'}, {'value': '64', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '76.44', 'spread': '19.02', 'groupId': 'BG000'}, {'value': '79.59', 'spread': '16.11', 'groupId': 'BG001'}, {'value': '86.19', 'spread': '15.33', 'groupId': 'BG002'}, {'value': '80.56', 'spread': '17.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weight in kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25.90', 'spread': '5.57', 'groupId': 'BG000'}, {'value': '28.81', 'spread': '4.72', 'groupId': 'BG001'}, {'value': '29.89', 'spread': '4.89', 'groupId': 'BG002'}, {'value': '28.13', 'spread': '5.32', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Body Mass Index in kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Total of 120 patients consented for the study. 15 patients were excluded from the study, leaving a total of 105 patients at study completion.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-28', 'size': 190324, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-12T11:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomized into one of three groups:\n\n1. Ultrasound guided LB Erector Spinae Plane Block with 20ml of Exparel and 10ml 0.25% bupivacaine\n2. Ultrasound guided SB Erector Spinae Plane Block with 30ml 0.5% bupivacaine\n3. Surgeon Infiltration under video guidance with 20ml of Exparel and 10ml of 0.25% bupivacaine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2019-02-28', 'resultsFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score at Rest', 'timeFrame': '24 hours pain score at rest', 'description': 'The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain'}, {'measure': 'The Primary Endpoint of This Study Will be 24 Hours VAS Pain Score With Movement', 'timeFrame': '24 hours pain score with movement', 'description': 'The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain'}, {'measure': 'The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score at Rest', 'timeFrame': '48 hours pain score at rest', 'description': 'The VAS score will be taken at rest using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain'}, {'measure': 'The Primary Endpoint of This Study Will be 48 Hours VAS Pain Score With Movement', 'timeFrame': '48 hours pain score with movement', 'description': 'The VAS score will be taken after movement (knee flexion) using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint Includes Total Opioid Consumption at 72 Hours', 'timeFrame': 'Opioid consumption will be measured at 72 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption between 48-72hr will be collected by a study team member per protocol time requirements'}, {'measure': 'Average Nausea Scores Over 72 Hours', 'timeFrame': 'Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged', 'description': 'Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as None=0, Mild=1, Moderate=2, Severe=3.'}, {'measure': 'Average Sedation Scores Over 72 Hours', 'timeFrame': 'Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the block. The scores will then be averaged.]', 'description': 'Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is Awake/Alert=0, Quietly Awake=1, Asleep but Arousable=2, or Deep Sleep=3'}, {'measure': 'Subjects Overall Satisfaction Scores at Hour 24', 'timeFrame': 'post operatively at hour 24', 'description': 'Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4'}, {'measure': 'Subjects Overall Satisfaction Scores at Hour 48', 'timeFrame': 'post operatively at hour 48', 'description': 'Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. The scores are collected as Very Unsatisfied=0, Unsatisfied=1, Neutral=2, Satisfied=3, Very Satisfied=4'}, {'measure': 'Secondary Endpoint Includes Total Opioid Consumption at 48 Hours', 'timeFrame': 'Opioid consumption will be measured at 48 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 24-48hr post op will be collected by a study team member per protocol time requirements'}, {'measure': 'Secondary Endpoint Includes Total Opioid Consumption at 24 Hours', 'timeFrame': 'Opioid consumption will be measured at 24 hours post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 1-24 hr postop will be collected by a study team member per protocol time requirements'}, {'measure': 'Secondary Endpoint Includes Total Opioid Consumption at 1 Hour', 'timeFrame': 'Opioid consumption will be measured at 1 hour post op. The total amount will be recorded.]', 'description': 'Opioid consumption at 1hr will be collected by a study team member per protocol time requirements'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pain', 'VATS'], 'conditions': ['Pain, Postoperative', 'Thoracic', 'Acute Pain']}, 'referencesModule': {'references': [{'pmid': '24336691', 'type': 'BACKGROUND', 'citation': 'Bottiger BA, Esper SA, Stafford-Smith M. Pain management strategies for thoracotomy and thoracic pain syndromes. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):45-56. doi: 10.1177/1089253213514484. Epub 2013 Dec 12.'}, {'pmid': '29491525', 'type': 'BACKGROUND', 'citation': 'Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb;62(2):148-150. doi: 10.4103/ija.IJA_726_17. No abstract available.'}, {'pmid': '29913392', 'type': 'BACKGROUND', 'citation': 'Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.'}, {'pmid': '29519230', 'type': 'BACKGROUND', 'citation': 'Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. No abstract available.'}, {'pmid': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '28919152', 'type': 'BACKGROUND', 'citation': 'Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.'}, {'pmid': '15232812', 'type': 'BACKGROUND', 'citation': 'Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.'}, {'pmid': '27443874', 'type': 'BACKGROUND', 'citation': 'Wu ZQ, Min JK, Wang D, Yuan YJ, Li H. Liposome bupivacaine for pain control after total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2016 Jul 22;11(1):84. doi: 10.1186/s13018-016-0420-z.'}, {'pmid': '29595645', 'type': 'BACKGROUND', 'citation': 'Yu ZX, Yang ZZ, Yao LL. Effectiveness of liposome bupivacaine for postoperative pain control in total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Mar;97(13):e0171. doi: 10.1097/MD.0000000000010171.'}, {'pmid': '28640101', 'type': 'BACKGROUND', 'citation': 'Ma TT, Wang YH, Jiang YF, Peng CB, Yan C, Liu ZG, Xu WX. Liposomal bupivacaine versus traditional bupivacaine for pain control after total hip arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(25):e7190. doi: 10.1097/MD.0000000000007190.'}, {'pmid': '29988796', 'type': 'BACKGROUND', 'citation': 'Raman S, Lin M, Krishnan N. Systematic review and meta-analysis of the efficacy of liposomal bupivacaine in colorectal resections. J Drug Assess. 2018 Jun 29;7(1):43-50. doi: 10.1080/21556660.2018.1487445. eCollection 2018.'}, {'pmid': '27505115', 'type': 'BACKGROUND', 'citation': 'Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.'}, {'pmid': '25897552', 'type': 'BACKGROUND', 'citation': 'Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5.'}, {'pmid': '24958971', 'type': 'BACKGROUND', 'citation': 'Noviasky J, Pierce DP, Whalen K, Guharoy R, Hildreth K. Bupivacaine liposomal versus bupivacaine: comparative review. Hosp Pharm. 2014 Jun;49(6):539-43. doi: 10.1310/hpj4906-539.'}, {'pmid': '21705236', 'type': 'RESULT', 'citation': 'Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thoracoscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):312-21. doi: 10.1053/j.jvca.2011.04.010. Epub 2011 Jun 25. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study is comparing the difference between erector spinae block and surgeon infiltration after VATS (Video Assisted Thoracoscopic Surgery). The outcomes measured are pain scores, opioid usage, opioid side effects, and patient satisfaction.We are also also studying the effectiveness of liposomal bupivacaine (EXPAREL) in a block by randomizing patients to both EXPAREL erector spinae block and simple bupivacaine erector spinae block.', 'detailedDescription': 'A total of 120 subjects will be randomized by a computer program into three groups (40 per group): The primary investigator will inform the anesthesiologist who will be doing the block as to what group the patients are randomized to. The research staff completing the patients assessments will be blinded to the randomization.\n\nFor the LB group (Ultrasound guided LB Erector Spinae Plane Block), patients should receive a total of 10ml 0.25% bupivacaine plus 20ml Exparel® (15ml at T4 and 15ml at T8) For the SB group (Ultrasound guided SB Erector Spinae Plane Block), patients should receive a total of 30ml 0.5% bupivacaine. (15ml at T4 and 15ml at T8) For the SI group (under video guidance) injected by surgeon using 10ml 0.25% bupivacaine plus 20ml Exparel\n\nAll the erector spinae plane blocks will be placed preoperatively after sedation, before intubation and prior to surgery. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.\n\nFor the ESP block, an ultrasound probe is used to visualize the ES musculature about 3 cm laterally from the spinous process. In a cephalad-to-caudad direction advance the needle and inject the anesthetic in the interfacial plane deep to the ES muscles. Confirm positioning by visualization of needle tip and elevation of ES muscles off the transverse process with anesthetic injection. Injection will be performed at T4 and T8 level.\n\nSurgeon infiltration is performed intraoperatively under direct thoracoscopic guidance. The intercostal space will be visualized and injected with LB. Typically, T4 through T8 are infiltrated with the anesthetic mixture.\n\nAll patients will be placed on ERAS protocol, which is our standard of practice.\n\nOpioid usage after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the surgery.\n\nAll patients will receive a phone call 6 months after surgery for assessment for chronic post-surgical pain. Patients will be assessed by a member of the research team over the phone. They will be assessed on their pain score and narcotic usage by using the Brief Pain Inventory. Study participation will conclude after the 6 month follow questionnaire has been completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pt undergoing VATS including but not limited to wedge or lobectomy at Indiana University Hospital\n* ASA 1,2,3 or 4\n* Age 18 or older, male or female\n* Desires regional anesthesia for postoperative pain control\n\nExclusion criteria:\n\n* Any contraindication for Erector Spinae Plane block\n* History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs\n* Patient staying intubated after surgery\n* Patient (home dose) taking more than 30mg PO morphine equivalent per day\n* Known allergy or other contraindications to the study medications, which include dilaudid and bupivacaine.\n* Pts. scheduled for a pleurodesis, decortication or esophagectomy at Indiana University Hospital'}, 'identificationModule': {'nctId': 'NCT03859635', 'briefTitle': 'Erector Spinae Block Versus Surgeon Infiltration in VATS Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Randomized Prospective Study Comparing Exparel Erector Spinae Plane Block vs Simple Bupivacaine Erector Spinae Plane Block vs Exparel Surgeon Infiltration for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '1809656804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided Liposomal Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.', 'interventionNames': ['Drug: Liposomal Bupivacaine', 'Drug: Bupivacaine, 0.25%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided Standard Bupivacaine Erector Spinae Block', 'description': 'All the erector spinae plane blocks will be placed preoperatively using Liposomal Buvicaine. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service or the attending anesthesiologist in the operating room.', 'interventionNames': ['Drug: Bupivacaine, 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgeon Infiltration', 'description': 'At the end of the surgery, the surgeon will infiltrate liposomal bupivacaine under thoracoscopic guidance along the intercostal nerves from T4-T8.', 'interventionNames': ['Drug: Liposomal Bupivacaine', 'Drug: Bupivacaine, 0.25%']}], 'interventions': [{'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'description': '20 ml', 'armGroupLabels': ['Surgeon Infiltration', 'Ultrasound guided Liposomal Bupivacaine Erector Spinae Block']}, {'name': 'Bupivacaine, 0.25%', 'type': 'DRUG', 'description': '10 ml', 'armGroupLabels': ['Surgeon Infiltration', 'Ultrasound guided Liposomal Bupivacaine Erector Spinae Block']}, {'name': 'Bupivacaine, 0.5%', 'type': 'DRUG', 'description': '30 ml', 'armGroupLabels': ['Ultrasound guided Standard Bupivacaine Erector Spinae Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Yar Yeap, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Anesthesiology. Director, Acute Pain Service', 'investigatorFullName': 'Yar Yeap', 'investigatorAffiliation': 'Indiana University'}}}}