Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

August 14, 2023 updated by: Daniel Katz, Icahn School of Medicine at Mount Sinai

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

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 (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
0.25%
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
0.25%
10ml
10mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Equivalents at 72 Hours
Time Frame: 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
Time Frame: 96 hours
Total cumulative opiates consumed converted to morphine equivalents
96 hours
Morphine Equivalents at 48 Hours
Time Frame: 48 hours
Total cumulative opiates consumed converted to morphine equivalents
48 hours
Opiate Sparing Criteria at 72 hours
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

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)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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