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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

NCT04272086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-11-12

No results posted yet for this study

Summary

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

Conditions

  • Fibroid Uterus

Interventions

DRUG

Bupivacaine

0.25%

DRUG

Bupivacaine liposome

10mL

DRUG

normal saline

10ml

Sponsors & Collaborators

Principal Investigators

  • Daniel Katz, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2025-10-28
Completion
2025-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272086 on ClinicalTrials.gov