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Liposomal Bupivacaine for Post-Surgery Pain in Fibroids

Phase 4
Recruiting
Led By Daniel Katz, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight over 50kg presenting for open myomectomy
No history of drug or alcohol use or abuse disorder or pre-existing liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
Drug Has Already Been Approved

Summary

This trial is testing whether a new type of painkiller (liposomal bupivacaine) reduces post-surgery pain and the amount of painkillers patients need, compared to the standard painkiller (bupivacaine).

Who is the study for?
This trial is for individuals over 50kg who are scheduled for open myomectomy surgery to remove fibroids and do not have a history of allergies to study medications, drug or alcohol abuse, liver disease, severe heart rhythm problems, epilepsy, seizures, or chronic pain other than from myomas.
What is being tested?
The trial is testing the effectiveness of two types of local anesthetics: liposomal bupivacaine versus standard bupivacaine. Patients will be randomly assigned to receive one of these during their surgery. The main focus is on whether these anesthetics reduce the need for opioid pain relief after surgery.
What are the potential side effects?
Possible side effects include reactions at the injection site such as pain or swelling, nausea, vomiting, constipation due to reduced opioid use if effective; rare allergic reactions may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh more than 50kg and am preparing for open surgery to remove fibroids.
Select...
I have no history of drug, alcohol abuse, or liver disease.
Select...
I don't have a history of severe heart rhythm problems, epilepsy, seizures, or chronic pain except from fibroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Morphine Equivalents at 72 Hours
Secondary study objectives
Area under the curve pain scale at 96 hours
Morphine Equivalents at 48 Hours
Morphine Equivalents at 96 Hours
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Liposomal bupivacaine TAPExperimental Treatment3 Interventions
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Group II: Bupivacaine TAPPlacebo Group2 Interventions
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Bupivacaine
FDA approved
normal saline
2010
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,665 Total Patients Enrolled
Daniel Katz, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School Of Medicine At Mount Sinai, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
7 Previous Clinical Trials
879 Total Patients Enrolled

Media Library

Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04272086 — Phase 4
Uterine Fibroids Research Study Groups: Bupivacaine TAP, Liposomal bupivacaine TAP
Uterine Fibroids Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT04272086 — Phase 4
Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04272086 — Phase 4
~22 spots leftby Sep 2025
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