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OpenTrials
Completed

NCT Number: NCT04272086

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

0.25%

Bupivacaine liposome

Drug

10mL

normal saline

Drug

10ml

Primary outcomes

  1. Morphine Equivalents at 72 Hours

    Time frame: 72 hours

    Total cumulative opiates consumed converted to morphine equivalents

Secondary outcomes

  1. Morphine Equivalents at 96 Hours

    Time frame: 96 hours

    Total cumulative opiates consumed converted to morphine equivalents

  2. Morphine Equivalents at 48 Hours

    Time frame: 48 hours

    Total cumulative opiates consumed converted to morphine equivalents

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2020
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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