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Local Anesthetic

Liposomal bupivacaine for Bunions

Phase 4
Waitlist Available
Led By Elliot Hershman, MD
Research Sponsored by Alexandra Black
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 the study will last 72 hours after the elective procedure.
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial compares two pain relief methods to find which is best for post-op pain management. Pain levels and OMEs used are measured over 72 hrs for comparison.

Eligible Conditions
  • Bunions
  • Forefoot Surgery
  • Opioid Use Disorder
  • Postoperative Pain
  • Liposomal Bupivacaine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the study will last 72 hours after the elective procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the study will last 72 hours after the elective procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain
Secondary study objectives
Effect of liposomal bupivacaine on opioid use

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal BupivacaineExperimental Treatment1 Intervention
The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure.
Group II: Bupivacaine HClActive Control1 Intervention
The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Alexandra BlackLead Sponsor
Elliot Hershman, MDPrincipal InvestigatorNorthwell Health
~19 spots leftby Nov 2025
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