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NCT04974385
Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty
Phase 3 trial testing Liposomal bupivacaine in Analgesia in 80 participants. Completed in 4 May 2022.
30 April 2022
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 4 August 2021 |
| Primary completion | 30 April 2022 |
| Estimated completion | 4 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Liposomal bupivacaine — full drug profile →
- Bupivacaine (BUPIVACAINE) — full drug profile →
Conditions studied
- Analgesia — all drugs for Analgesia →
Sponsor
University of Virginia
Who can join
18 and older, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and 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 NCT04974385
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Currently open trials in the same condition.
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Other University of Virginia 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 NCT04974385 (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 Virginia
- Last refreshed: 3 November 2022
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/NCT04974385.
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