Status:

COMPLETED

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Conditions:

Fibroid Uterus

Eligibility:

FEMALE

18-64 years

Phase:

PHASE4

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 te...

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 bl...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 9 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 28 2025

    Estimated Enrollment :

    140 Patients enrolled

    Trial Details

    Trial ID

    NCT04272086

    Start Date

    November 9 2020

    End Date

    October 28 2025

    Last Update

    November 12 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Icahn School of Medicine at Mount Sinai

    New York, New York, United States, 10029