Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
Public ClinicalTrials.gov record NCT05157841. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL vs. Bupivacaine Hydrochloric Acid (HCl) Administered as a Sciatic (in the Popliteal Fossa) Nerve Block for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL. Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.
Study identification
- NCT ID
- NCT05157841
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 185 participants
Conditions and interventions
Conditions
Interventions
- Bupivacaine liposome injectable suspension 266 mg Drug
- Bupivacaine HCl Drug
- Bupivacaine liposome injectable suspension 133 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2022
- Primary completion
- Aug 16, 2022
- Completion
- Aug 16, 2022
- Last update posted
- Jun 25, 2025
2022
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Surgical Hospital | North Little Rock | Arkansas | 72118 | — |
| Lotus Clinical Research | Pasadena | California | 91105 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| HD Research- First Surgical Hospital | Bellaire | Texas | 77401 | — |
| HD Research-Legent Orthopedic Hospital | Carrollton | Texas | 75006 | — |
| Houston Heights Hospital | Houston | Texas | 77008 | — |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05157841, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05157841 live on ClinicalTrials.gov.