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NCT04518462 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT04518462: Completed Phase 3 study, sponsored by Pacira Pharmaceuticals.
NCT04518462 is a Phase 3 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04518462, a Phase 3 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
Primary Outcome
To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries. Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surge
Interventions
- DRUG Exparel
- DRUG Bupivacaine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2021-04-05 |
| Phase | Phase 3 |
What the finished NCT04518462 record still lists
NCT04518462 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Exparel is the first listed.
NCT04518462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04518462 about?
NCT04518462 is a clinical study titled "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". This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
What is the current status of trial NCT04518462?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2020-10-20. Estimated completion is 2021-04-05.
What interventions are being tested in trial NCT04518462?
The interventions under investigation include: Exparel (DRUG), Bupivacaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04518462?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04518462's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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