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NCT04191031
Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
NA trial testing ioveraº in Post-Operative Pain Management in 79 participants. Terminated before completion.
13 May 2022
Quick facts
| Lead sponsor | Pacira Pharmaceuticals, Inc |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 79 |
| Start date | 30 September 2020 |
| Primary completion | 13 May 2022 |
| Estimated completion | 12 July 2022 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- ioveraº
- ioveraº sham
Conditions studied
- Post-Operative Pain Management — all drugs for Post-Operative Pain Management →
Sponsor
Pacira Pharmaceuticals, Inc — full company profile →
Who can join
22 and older, any sex, with Post-Operative Pain Management. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04191031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Pacira Pharmaceuticals, Inc trials
Trials by the same sponsor.
- NCT06977568 — A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjec · Phase 2 · terminated
- NCT05456490 — Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13. · Phase 1 · completed
- NCT05157841 — Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy · Phase 3 · completed
- NCT05139030 — Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty · Phase 3 · completed
- NCT05495334 — Innovations in Genicular Outcomes Registry · recruiting
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 NCT04191031 (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 Pacira Pharmaceuticals, Inc
- Last refreshed: 25 January 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/NCT04191031.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing