← Back to Search

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morphine Equivalents at 72 Hours

Secondary outcome measures

Area under the curve pain scale at 96 hours

Morphine Equivalents at 48 Hours

Morphine Equivalents at 96 Hours

+3 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

867 Previous Clinical Trials

526,777 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

5 Previous Clinical Trials

669 Total Patients Enrolled

Media Library

Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04272086 — Phase 4

Fibroid Research Study Groups: Bupivacaine TAP, Liposomal bupivacaine TAP

Fibroid Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT04272086 — Phase 4

Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04272086 — Phase 4

Frequently Asked Questions

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

What is the participant quota of this clinical experiment?

"Affirmative, clinicaltrials.gov reveals that this trial is currently seeking participants. It was initially listed on November 9th 2020 and the most recent update occurred on October 19th 2022. 140 volunteers are needed to be enrolled across a single site."

Answered by AI

Are new participants being welcomed into this research endeavor?

"Clinicaltrials.gov confirms that this medical study, which was initially posted on November 9th 2020, is actively seeking participants. The trial's information has been revised as recently as October 19th 2022."

Answered by AI

Are there other investigations that have utilized Bupivacaine as a primary agent?

"At the moment, there are 109 studies currently investigating Bupivacaine. Of those examinations, eighteen have reached Phase 3 of their clinical trial process. While much of the research is based in Philadelphia, Pennsylvania, it is being conducted at 144 distinct sites across the USA."

Answered by AI

What medical conditions can Bupivacaine be employed to alleviate?

"Bupivacaine is a promising treatment for pemphigus and other medical ailments such as acute nonspecific tenosynovitis, general anesthesia, or lupus erythematosus cell."

Answered by AI

Is this research recruiting geriatric participants?

"Per the outlined guidelines, potential participants must be of age 18 years or older and not exceed 64 years."

Answered by AI

Am I eligible to enroll in this research initiative?

"The requirements for this research project necessitates that participants possess a fibroid uterus and be between 18 to 64 years old. This trial hopes to enrol 140 prospective individuals in total."

Answered by AI