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Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy

NCT05157841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2025-06-26

Study results available
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Summary

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.

Conditions

  • Bunionectomy
  • Hallux Valgus

Interventions

DRUG

Bupivacaine liposome injectable suspension 266 mg

Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg

DRUG

Bupivacaine HCl

Sciatic nerve block in the popliteal fossa with Bupivacaine HCl

DRUG

Bupivacaine liposome injectable suspension 133 mg

Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Gary Nevins · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-08-17
Completion
2022-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05157841 on ClinicalTrials.gov