Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT06179004
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'As participants are enrolled in this study, a study identification will be created as their basic demographic information is entered into the secure RedCap database. At this time, the RedCap randomization tool will randomize the subject to either group 1 or 2.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interim analysis will be performed when data collection is complete for 40 participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-operative and 48-hour Post-operative Quality of Recovery 15 survey score', 'timeFrame': 'Pre-operative and at 24 hours and 48 hours post-operative', 'description': 'The quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative recovery. Scale is based on 15 questions, each question score range is 0-10 (0 being poor and 10 being excellent) The survey will be conducted at 24 hours intervals after surgery up to 48 hours total after surgery. The total score range is 0-150, where a score of 0 would be the worst possible score, and 150 would be the best possible score'}], 'secondaryOutcomes': [{'measure': 'Difference in Participant Reported Pain Scores', 'timeFrame': 'Post-operative period up to 48 hours after surgery', 'description': 'These pain scores will be collected immediately after surgery in the recovery room, and on postoperative days 1 and 2 during follow up telephone encounters. The estimate of interest is the difference in patient reported pain scores (numeric 0-10) between groups at these points in time.'}, {'measure': 'Time to First Dose of Opioid Medication', 'timeFrame': 'Post-operative period up to 48 hours after surgery', 'description': 'Investigate opioid medication consumption by recording time to first opioid medication administered.'}, {'measure': 'Total opioid dose through Post-op Day 2', 'timeFrame': 'Post-operative period up to 48 hours after surgery', 'description': 'Investigate opioid medication consumption by recording total opioid dose for each group through postoperative day 2.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fractures', 'Wrist Fractures']}, 'referencesModule': {'references': [{'pmid': '24496168', 'type': 'RESULT', 'citation': 'Abell DJ, Barrington MJ. Pneumothorax after ultrasound-guided supraclavicular block: presenting features, risk, and related training. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):164-7. doi: 10.1097/AAP.0000000000000045.'}, {'pmid': '36752544', 'type': 'RESULT', 'citation': 'Brown CA, Ghanouni A, Williams R, Payne SH, Ghareeb PA. Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S332-S336. doi: 10.1097/SAP.0000000000003464. Epub 2023 Jan 31.'}, {'pmid': '33372953', 'type': 'RESULT', 'citation': 'Hussain N, Brull R, Sheehy B, Essandoh MK, Stahl DL, Weaver TE, Abdallah FW. Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. Anesthesiology. 2021 Feb 1;134(2):147-164. doi: 10.1097/ALN.0000000000003651.'}, {'pmid': '35430086', 'type': 'RESULT', 'citation': 'Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.'}, {'pmid': '31274718', 'type': 'RESULT', 'citation': 'Rundgren J, Mellstrand Navarro C, Ponzer S, Regberg A, Serenius S, Enocson A. Regional or General Anesthesia in the Surgical Treatment of Distal Radial Fractures: A Randomized Clinical Trial. J Bone Joint Surg Am. 2019 Jul 3;101(13):1168-1176. doi: 10.2106/JBJS.18.00984.'}, {'pmid': '36458106', 'type': 'RESULT', 'citation': 'Schoenherr JW, Gonzalez M, Serrano R, Park M, Lee Z, Cobb K, Howard C, Flynn D, Li Q, Grant S, Bullard T. Quality of Recovery After Rotator Cuff Repair With Interscalene Liposomal Bupivacaine Versus Interscalene Nerve Catheter. Orthop J Sports Med. 2022 Nov 22;10(11):23259671221134819. doi: 10.1177/23259671221134819. eCollection 2022 Nov.'}, {'pmid': '26787793', 'type': 'RESULT', 'citation': 'Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.'}, {'type': 'RESULT', 'citation': "D'Souza RS, Johnson RL. Supraclavicular Block. [Updated 2023 Jan 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK519056/"}, {'pmid': '27159009', 'type': 'RESULT', 'citation': 'Myles PS, Myles DB, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology. 2016 Jul;125(1):39-45. doi: 10.1097/ALN.0000000000001158.'}]}, 'descriptionModule': {'briefSummary': "Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of upper extremity surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators' goal is to evaluate the effectiveness of Exparel as compared to plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.", 'detailedDescription': 'Purpose: Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators goal is to evaluate the effectiveness of Exparel as compared to the investigators prior standard practice of using plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.\n\nParticipants: Adult participants age \\> 18 undergoing orthopedic wrist surgery at the University of North Carolina ambulatory surgery center and University of North Carolina Hillsborough campus Exclusion Criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these subjects with no additional exclusion criteria.- Contraindications to regional anesthesia- Significant peripheral neuropathy or neurological disorder affecting the upper extremity- Pregnancy- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.\n\nProcedures (methods): This is a prospective, randomized comparison of participants undergoing orthopedic wrist procedures that receive one of two types of supraclavicular nerve block. Group 1 will be comprised of patients with a preoperative supraclavicular nerve block placed with 20 mL 0.5% bupivacaine. Group 2 will be comprised of participants with a preoperative supraclavicular nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All subjects in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications. Outcomes measured by Post anesthesia care unit assessment and telephone follow up: see uploaded data collection form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18\n* Scheduled for orthopedic wrist surgery at University of North Carolina at Chapel Hill.\n\nExclusion Criteria:\n\n* Contraindications to regional anesthesia\n* Emergent surgery Open fractures will be treated emergently and will not allow adequate lead time for enrollment in this study. Also, open fractures are usually accompanied by other traumatic injuries that would confound the pain related outcomes in this study.\n* Significant peripheral neuropathy or neurological disorder affecting the upper extremity\n* Pregnancy Pregnant women have physiologic changes that make them more sensitive to local anesthetics. That would introduce a confounding element in interpreting the effectiveness of the peripheral nerve blocks being studied.\n* Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06179004', 'acronym': 'Vs', 'briefTitle': 'Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Randomized Controlled Trial of Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery', 'orgStudyIdInfo': {'id': '23-1116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supraclavicular Liposomal Bupivacaine group', 'description': 'This group will receive the liposomal bupivacaine', 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supraclavicular Plain Bupivacaine group', 'description': 'This group will receive the plain bupivacaine', 'interventionNames': ['Drug: Bupivacaine Hydrochloride']}], 'interventions': [{'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'otherNames': ['Exparel'], 'description': '133mg Liposomal bupivacaine plus 10mL 0.5% bupivacaine administered in a supraclavicular single shot perineural injection', 'armGroupLabels': ['Supraclavicular Liposomal Bupivacaine group']}, {'name': 'Bupivacaine Hydrochloride', 'type': 'DRUG', 'description': '20mL 0.25% bupivacaine administered in a supraclavicular single shot perineural injection', 'armGroupLabels': ['Supraclavicular Plain Bupivacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jay Schoenherr, MD', 'role': 'CONTACT', 'email': 'Jay_Schoenherr@med.unc.edu', 'phone': '919-951-5062'}], 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Jay Schoenherr, MD', 'role': 'CONTACT', 'email': 'jay_schoenherr@med.unc.edu', 'phone': '9199515062'}], 'overallOfficials': [{'name': 'Jay Schoenherr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}