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NCT03929146 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine Versus Interscalene Nerve Block
A Phase 4 study of Pain, Postoperative, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT03929146: Completed Phase 4 study of Pain, Postoperative, sponsored by University of Cincinnati.
NCT03929146 is a Phase 4 study of Pain, Postoperative that has completed, run by University of Cincinnati. The registered enrollment target is 76 participants, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03929146, a Phase 4 study of Pain, Postoperative, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, Parsippany NJ). Specifically, the primary aims of this study are to compare these two interventions on the following: post-operative opioid consumption, pain scores, and patient satisfaction. Additionally, the investigators want to determine if psychological factors, catastrophizing and resilience, are associated with post-operative pain control and satisfaction. The investigators' hypothesis is that the two interventions will have similar pain control efficacy and that the liposomal bupivacaine group will experience faster post-operative recovery, earlier discharge, and improved satisfaction. The investigators also expect patient catastrophizing and resilience to significantly predict the degree of post-operative pain and level of patient satisfaction.
Primary Outcome
Post-operative use of opioid pain medications, measured in morphine equivalents (higher scores are worse)
Conditions Studied
Interventions
- DRUG Exparel
- PROCEDURE Interscalene Nerve Block
Study Locations (1)
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2019-02-05 |
| Est. Completion | 2022-11-01 |
| Phase | Phase 4 |
What the finished NCT03929146 record still lists
NCT03929146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Exparel is the first listed.
NCT03929146 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03929146 about?
NCT03929146 is a clinical study titled "Liposomal Bupivacaine Versus Interscalene Nerve Block". The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty. The two interventions are 1) pre-operative interscalene nerve block and 2) intraoperative injection of liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, P...
What is the current status of trial NCT03929146?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 76 participants. The study started on 2019-02-05. Estimated completion is 2022-11-01.
What conditions does trial NCT03929146 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT03929146?
The interventions under investigation include: Exparel (DRUG), Interscalene Nerve Block (PROCEDURE).
Who is sponsoring clinical trial NCT03929146?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03929146 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03929146's enrollment target sits among peer trials
76 64th of 113 higher than 49 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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