Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

NCT04272086 | Completed Phase 4 FDA Drug

• 1 other identifier: GCO 19-1807
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibroid uterus; Myomectomy; Abdominal myomectomy

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalents at 72 Hours

  Total cumulative opiates consumed converted to morphine equivalents

  72 hours

Secondary Outcomes (6)

• Morphine Equivalents at 96 Hours

  96 hours

• Morphine Equivalents at 48 Hours

  48 hours

• Opiate Sparing Criteria at 72 hours

  72 hours

• Quality of Recovery at 48 hours

  48 hours

• Quality of Recovery at 72 hours

  72 hours

Study Arms (2)

Bupivacaine TAP

PLACEBO COMPARATOR

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

Drug: Bupivacaine; Drug: normal saline

Liposomal bupivacaine TAP

EXPERIMENTAL

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Drug: Bupivacaine; Drug: Bupivacaine liposome; Drug: normal saline

Interventions

Bupivacaine DRUG

0.25%

Bupivacaine TAP; Liposomal bupivacaine TAP

Bupivacaine liposome DRUG

10mL

Liposomal bupivacaine TAP

normal saline DRUG

10ml

Bupivacaine TAP; Liposomal bupivacaine TAP

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Only women have uterine fibroids
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not pregnant
• Weight over 50kg presenting for open myomectomy
• No history of allergy to any study medication
• No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
• No history of drug or alcohol use or abuse disorder or pre-existing liver disease.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Daniel Katz, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: November 9, 2020
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)