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NCT04293809
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
Phase 1 trial testing Exparel Injectable Product in Breast Augmentation in 30 participants. Completed in 29 January 2020.
15 January 2020
Quick facts
| Lead sponsor | Pacira Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 19 December 2019 |
| Primary completion | 15 January 2020 |
| Estimated completion | 29 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Exparel Injectable Product
- Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) — full drug profile →
Conditions studied
- Breast Augmentation — all drugs for Breast Augmentation →
Sponsor
Pacira Pharmaceuticals, Inc — full company profile →
Who can join
18 and older, female only, with Breast Augmentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
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 NCT04293809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Exparel Injectable Product
Trials testing the same drug.
- NCT05355597 — "The Efficacy of Exparel Versus a Multidrug Cocktail in Soft Tissue Tumors" · Phase 2 · terminated
- NCT04002089 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In · Phase 1 · completed
- NCT03270514 — Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride · Phase 3 · completed
- NCT04781075 — Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery · Phase 4 · completed
Other recruiting trials for Breast Augmentation
Currently open trials in the same condition.
- NCT07448246 — Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery · NA · recruiting
- NCT06274736 — Safety and Performance of Motiva® Sizers · recruiting
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 NCT04293809 (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: 29 January 2024
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/NCT04293809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing