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Local Anesthetic

Part B: EXPAREL 133 mg arm OR EXPAREL 266 mg arm for Bunions

Phase 3
Waitlist Available
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours, 0-48 hours, 0-72 hours, and 0-96 hours post-surgery
Awards & highlights

Study Summary

The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on 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.

Eligible Conditions
  • Bunions
  • Bunionectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours, 0-48 hours, 0-72 hours, and 0-96 hours post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours, 0-48 hours, 0-72 hours, and 0-96 hours post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NRS pain scores through 96 hours post-surgery
Secondary outcome measures
First opioid consumption post-surgery
NRS pain scores 24h, 48h, 72h, and 96h post-surgery
Opioid consumption through 96 hours post-surgery
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Part B: EXPAREL 133 mg arm OR EXPAREL 266 mg armExperimental Treatment2 Interventions
Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline OR 10 mL (133 mg) EXPAREL mixed with 20 mL saline. Dose will be determined following interim analysis of Part A.
Group II: Part A: EXPAREL 266 mg armExperimental Treatment1 Intervention
subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline
Group III: Part A: EXPAREL 133 mg armExperimental Treatment1 Intervention
subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL mixed with 20 mL saline
Group IV: Part B: Bupivacaine HCl armActive Control1 Intervention
subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline
Group V: Part A: Bupivacaine HCl armActive Control1 Intervention
Subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine liposome injectable suspension 266 mg
2022
Completed Phase 3
~190
Bupivacaine liposome injectable suspension 133 mg
2022
Completed Phase 3
~190

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
136 Previous Clinical Trials
13,848 Total Patients Enrolled
Gary NevinsStudy DirectorPacira Pharmaceuticals, Inc
1 Previous Clinical Trials
167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Memorial Hermann Village
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
2022. "Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157841.
~58 spots leftby Apr 2025
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