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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

NCT ID: NCT04272086

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2025-10-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibroid Uterus

Keywords

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Fibroid uterus Myomectomy Abdominal myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Bupivacaine TAP

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

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

0.25%

normal saline

Intervention Type DRUG

10ml

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

0.25%

Bupivacaine liposome

Intervention Type DRUG

10mL

normal saline

Intervention Type DRUG

10ml

Interventions

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Bupivacaine

0.25%

Intervention Type DRUG

Bupivacaine liposome

10mL

Intervention Type DRUG

normal saline

10ml

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Daniel Katz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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GCO 19-1807

Identifier Type: -

Identifier Source: org_study_id