Trials / Completed
CompletedNCT04518462
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic (in Popliteal Fossa) and Saphenous (in Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Pacira Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
Conditions
- Lower Extremity Surgery
- Bunion
- Metatarsophalangeal Fushion
- Midfoot Fusion
- Hindfoot Fushion
- Total Ankle Arthroplasty
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Exparel | EXPAREL (bupivacaine liposome injectable suspension) |
| DRUG | Bupivacaine Hydrochloride | 0.25% bupivacaine |
Timeline
- Start date
- 2020-10-20
- Primary completion
- 2021-04-05
- Completion
- 2021-04-05
- First posted
- 2020-08-19
- Last updated
- 2022-07-18
- Results posted
- 2022-07-18
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04518462. Inclusion in this directory is not an endorsement.