Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179004
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-12-11
Brief Title:
Supraclavicular Bupivacaine Vs Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Randomized Controlled Trial of Supraclavicular Bupivacaine Vs Supraclavicular Liposomal Bupivacaine for Distal Radius Fracture Repair
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vs
Brief Summary:
Distal radius fracture repair often causes 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
Detailed Description:
Purpose Distal radius fracture repair often causes 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
Participants Adult participants age 18 undergoing distal radius fracture repair 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 andor inability to provide informed consent
Procedures methods This is a prospective randomized comparison of participants undergoing distal radius fracture repair 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 05 bupivacaine Group 2 will be comprised of participants with a preoperative supraclavicular nerve block placed with 10 mL 05 bupivacaine and 10 mL 13 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
Participants Adult participants age 18 undergoing distal radius fracture repair 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 andor inability to provide informed consent
Procedures methods This is a prospective randomized comparison of participants undergoing distal radius fracture repair 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 05 bupivacaine Group 2 will be comprised of participants with a preoperative supraclavicular nerve block placed with 10 mL 05 bupivacaine and 10 mL 13 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None