Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-22 @ 2:37 PM
Study NCT ID:
NCT03642457
Status:
TERMINATED
Last Update Posted:
2020-09-30
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Between Serratus Plane Block And Local Infiltration In Vats
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': 'poonam.paibantwalhebbalasankatte@mountsinai.org', 'phone': '347-569-4816', 'title': 'Poonam Pai', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Amount of Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'classes': [{'categories': [{'measurements': [{'value': '18.93', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '13.21', 'spread': '18.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours post procedure', 'description': 'The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.', 'unitOfMeasure': 'MME', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Dose of Narcotic Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'classes': [{'categories': [{'measurements': [{'value': '2.86', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '3.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours post procedure', 'description': 'Time to first dose of narcotic administration post procedure', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PACU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'classes': [{'categories': [{'measurements': [{'value': '3.45', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'average 3-4 hours post procedure', 'description': 'The length of stay post procedure in the PACU', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'classes': [{'categories': [{'measurements': [{'value': '32.57', 'spread': '28.32', 'groupId': 'OG000'}, {'value': '40.00', 'spread': '27.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 40 hours post procedure', 'description': 'The length of stay post procedure in the or ICU', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only those participants who required an ICU stay'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Score (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.31', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '3.65', 'groupId': 'OG001'}]}]}, {'title': 'at 2 hours', 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'at 6 hours', 'categories': [{'measurements': [{'value': '3.03', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'at 18 hours', 'categories': [{'measurements': [{'value': '2.17', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'at 24 hours', 'categories': [{'measurements': [{'value': '1.89', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '2.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 hours post procedure', 'description': 'Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'timeFrame': 'up to 24 hours post procedure', 'description': 'Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.29', 'spread': '17.24', 'groupId': 'BG000'}, {'value': '64.30', 'spread': '11.01', 'groupId': 'BG001'}, {'value': '58.37', 'spread': '15.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'missing data'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-08', 'size': 466671, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-03T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient, surgeon, and anesthesiologist in the case will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'whyStopped': 'PI left institution and unable to find new PI', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-11', 'studyFirstSubmitDate': '2018-08-20', 'resultsFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-03', 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Opioid Consumption', 'timeFrame': 'up to 24 hours post procedure', 'description': 'The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.'}], 'secondaryOutcomes': [{'measure': 'Time to First Dose of Narcotic Administration', 'timeFrame': 'up to 24 hours post procedure', 'description': 'Time to first dose of narcotic administration post procedure'}, {'measure': 'PACU Length of Stay', 'timeFrame': 'average 3-4 hours post procedure', 'description': 'The length of stay post procedure in the PACU'}, {'measure': 'ICU Length of Stay', 'timeFrame': 'up to 40 hours post procedure', 'description': 'The length of stay post procedure in the or ICU'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': 'up to 24 hours post procedure', 'description': 'Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': 'up to 24 hours post procedure', 'description': 'Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video assisted thoracoscopic surgery', 'Serratus plane block', 'local infiltration'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '27543533', 'type': 'BACKGROUND', 'citation': 'Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.'}, {'pmid': '21831090', 'type': 'BACKGROUND', 'citation': "Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available."}, {'type': 'BACKGROUND', 'citation': 'Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.'}]}, 'descriptionModule': {'briefSummary': 'Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.\n\nSerratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.\n\nThe lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.\n\nThe purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.', 'detailedDescription': 'Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiology) class I-IV\n* age 81-75\n\nExclusion Criteria:\n\n* ASA class V\n* morbid obesity\n* patient refusal\n* patients with chronic pain or on pain medications\n* allergy to LA\n* patients receiving any additional regional techniques\n* coagulopathy\n* patients receiving systemic anticoagulation\n* local infection\n* procedures anticipated to last more than 5 hours.'}, 'identificationModule': {'nctId': 'NCT03642457', 'briefTitle': 'Efficacy Between Serratus Plane Block And Local Infiltration In Vats', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GCO 17-1294'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Serratus Plane Group', 'description': 'Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound.', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Bupivacaine liposome']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': "Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice.", 'interventionNames': ['Drug: Bupivacaine liposome']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': '20 cc 0.5%', 'armGroupLabels': ['Serratus Plane Group']}, {'name': 'Bupivacaine liposome', 'type': 'DRUG', 'description': '133mg liposomal bupivacaine', 'armGroupLabels': ['Placebo Group', 'Serratus Plane Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Mount Sinai St. Luke's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai West Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Yan Lai, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'cahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yan Lai', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}