Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Fibroid Uterus
• Intervention / Treatment: Drug: Bupivacaine; Drug: normal saline; Drug: Bupivacaine liposome

Detailed Description

After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Bupivacaine TAP; TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side	Drug: Bupivacaine; 0.25%; Drug: normal saline; 10ml
Experimental: Liposomal bupivacaine TAP; TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side	Drug: Bupivacaine; 0.25%; Drug: normal saline; 10ml; Drug: Bupivacaine liposome; 10mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalents at 72 Hours	Total cumulative opiates consumed converted to morphine equivalents	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalents at 96 Hours	Total cumulative opiates consumed converted to morphine equivalents	96 hours
Morphine Equivalents at 48 Hours	Total cumulative opiates consumed converted to morphine equivalents	48 hours
Opiate Sparing Criteria at 72 hours	Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale. Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit.	72 hours
Quality of Recovery at 48 hours	15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.	48 hours
Quality of Recovery at 72 hours	15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.	72 hours
Area under the curve pain scale at 96 hours	Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.	96 hours

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Myomectomy; Fibroid uterus; Abdominal myomectomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Bupivacaine; Saline Solution
• Other Study ID Numbers: GCO 19-1807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No