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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

NCT04518462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-07-18

Study results available
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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

DRUG

Exparel

EXPAREL (bupivacaine liposome injectable suspension)

DRUG

Bupivacaine Hydrochloride

0.25% bupivacaine

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2021-04-05
Completion
2021-04-05
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 NCT04518462 on ClinicalTrials.gov