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NCT03929146
Liposomal Bupivacaine Versus Interscalene Nerve Block
Phase 4 trial testing Exparel in Pain, Postoperative in 76 participants. Completed in 1 November 2022.
1 November 2022
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 5 February 2019 |
| Primary completion | 1 November 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Exparel — full drug profile →
- Interscalene Nerve Block — full drug profile →
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
University of Cincinnati
Who can join
18 and older, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03929146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Exparel
Trials testing the same drug.
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- NCT06350981 — Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion · Phase 2, PHASE3 · enrolling by invitation
- NCT06274008 — Exparel vs. ACB With Bupivacaine for ACL Reconstruction · Phase 1 · unknown
Other recruiting trials for Pain, Postoperative
Currently open trials in the same condition.
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Other University of Cincinnati trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03929146 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 10 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03929146.
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