Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
Study NCT ID:
NCT04005859
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2019-06-27
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': 'kevin.kasten@atriumhealth.org', 'phone': '704-355-1813', 'title': 'Dr. Kevin Kasten', 'organization': 'Atrium Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1. Opioid consumption was quite varied amongst patients, possibly contributing to underpowered study.\n2. Inconsistent recording of VAS while inpatient\n3. Inconsistent recording of VAS while undergoing 2 and 4 week post-op follow-up (clinic vs phone)\n4. Difficult to completely account for OME based on potential for outside prescriptions not seen by researchers.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks from date of surgery (scheduled time of post-op clinic visit addressing primary endpoint of total OME utilized by patient)', 'eventGroups': [{'id': 'EG000', 'title': 'CONTROL: IV Lido', 'description': 'CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)\n\nIV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35\n\n1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.\n2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.\n3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EXPERIMENTAL: Exparel', 'description': 'EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)\n\nExparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35\n\n1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.\n2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.\n3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.\n4. Adhesive tapes will be applied at the level of the TAP block puncture sites.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Verbal Pain Scale (VRS) - 4 Week Post-op', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CONTROL: IV Lido', 'description': 'CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)\n\nIV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35\n\n1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.\n2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.\n3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.'}, {'id': 'OG001', 'title': 'EXPERIMENTAL: Exparel', 'description': 'EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)\n\nExparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35\n\n1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.\n2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.\n3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.\n4. Adhesive tapes will be applied at the level of the TAP block puncture sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single VRS assessed at 4-week post-op visit (or phone call)', 'description': 'Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CONTROL: IV Lido', 'description': 'CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)\n\nIV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35\n\n1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.\n2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.\n3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.'}, {'id': 'FG001', 'title': 'EXPERIMENTAL: Exparel', 'description': 'EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)\n\nExparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35\n\n1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.\n2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.\n3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.\n4. Adhesive tapes will be applied at the level of the TAP block puncture sites.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CONTROL: IV Lido', 'description': 'CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)\n\nIV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35\n\n1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.\n2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.\n3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.'}, {'id': 'BG001', 'title': 'EXPERIMENTAL: Exparel', 'description': 'EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)\n\nExparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35\n\n1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.\n2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.\n3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.\n4. Adhesive tapes will be applied at the level of the TAP block puncture sites.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '14', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'On Steroids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'H/O Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Tobacco Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior intra-abdominal surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Procedure was robotic-assisted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-07', 'size': 221253, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-24T08:43', 'hasProtocol': True}, {'date': '2018-06-06', 'size': 232142, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-05T12:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2019-06-27', 'resultsFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-20', 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verbal Pain Scale (VRS) - 4 Week Post-op', 'timeFrame': 'Single VRS assessed at 4-week post-op visit (or phone call)', 'description': 'Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Disorders']}, 'descriptionModule': {'briefSummary': 'To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Elective laparoscopic colorectal surgery\n* ASA I-III\n\nExclusion Criteria:\n\n* Contraindication to Na Channel Blocker\n* Chronic Opioid use\n* Liver dysfunction\n* Renal insufficiency\n* Epilepsy\n* Psychomotor retardation\n* BMI \\>40\n* Sleep Apnea\n* Cardiac Rhythm Disorders\n* Planned open or concomitant procedure'}, 'identificationModule': {'nctId': 'NCT04005859', 'acronym': 'Exparel', 'briefTitle': 'Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane', 'orgStudyIdInfo': {'id': '01-18-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL: IV Lido', 'description': 'CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)', 'interventionNames': ['Drug: IV Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'EXPERIMENTAL: Exparel', 'description': 'EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)', 'interventionNames': ['Drug: Exparel']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'description': '2\\. Liposomal bupivacaine TAP block (experimental arm)\n\n1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.\n2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.\n3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.\n4. Adhesive tapes will be applied at the level of the TAP block puncture sites.', 'armGroupLabels': ['EXPERIMENTAL: Exparel']}, {'name': 'IV Lidocaine', 'type': 'DRUG', 'description': '1\\. Intravenous Lidocaine infusion (control arm, current standard of care)\n\n1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.\n2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.\n3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.', 'armGroupLabels': ['CONTROL: IV Lido']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health - Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Kevin Kasten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}