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NCT06179004 · ClinicalTrials.gov registry record · Phase 3

Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery

A Phase 3 study of Distal Radius Fractures and Wrist Fractures, sponsored by University of North Carolina, Chapel Hill.

Recruiting
Registry status
Phase 3
Development phase
100
Enrollment target
1
Study location

NCT06179004: Recruiting Phase 3 study of Distal Radius Fractures and Wrist Fractures, sponsored by University of North Carolina, Chapel Hill.

NCT06179004 is a Phase 3 study of Distal Radius Fractures and Wrist Fractures that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 100 participants, below the 171-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06179004, a Phase 3 study of Distal Radius Fractures and Wrist Fractures, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.

RECRUITING
Registry status
Phase 3
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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

Conditions Studied

Distal Radius Fractures Wrist Fractures

Interventions

  • DRUG Liposomal bupivacaine
  • DRUG Bupivacaine Hydrochloride

Study Locations (1)

North Carolina

  • UNC Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-04-10
Est. Completion 2026-10
Phase Phase 3
University of North Carolina, Chapel Hill

1,109 total trials

What NCT06179004 shows while recruiting

NCT06179004 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 171-participant average among 4 other Distal Radius Fractures trials with a reported enrollment target (42% lower).

The record links to 2 conditions, with Distal Radius Fractures appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine is the first listed.

NCT06179004 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT06179004 about?

NCT06179004 is a clinical study titled "Supraclavicular Bupivacaine Vs. Supraclavicular Liposomal Bupivacaine for Orthopedic Wrist Surgery". 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 arou...

What is the current status of trial NCT06179004?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2024-04-10. Estimated completion is 2026-10.

What conditions does trial NCT06179004 study?

This clinical trial studies the following conditions: Distal Radius Fractures, Wrist Fractures.

What interventions are being tested in trial NCT06179004?

The interventions under investigation include: Liposomal bupivacaine (DRUG), Bupivacaine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT06179004?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06179004 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06179004

Source: ClinicalTrials.gov NCT06179004, the US trial registry maintained by the National Library of Medicine. NCT06179004 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.