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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
Study 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
- Liposomal Bupivacaine
- Postoperative Pain
- Forefoot Surgery
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the study will last 72 hours after the elective procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the study will last 72 hours after the elective procedure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Effect of liposomal bupivacaine on opioid use
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
Frequently Asked Questions
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