QL Block in Laparoscopic Myomectomy

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-24

Study Completion Date

2026-07-03

Brief Summary

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This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.

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Detailed Description

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Conditions

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Postoperative Pain Fibroid Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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QL Block with Bupivacaine

Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

30cc IM injection in each quadratus lumborum muscle (60cc total).

Control

Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).

Group Type SHAM_COMPARATOR

Saline

Intervention Type DRUG

30cc IM injection in each quadratus lumborum muscle (60cc total).

Interventions

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Bupivacain

30cc IM injection in each quadratus lumborum muscle (60cc total).

Intervention Type DRUG

Saline

30cc IM injection in each quadratus lumborum muscle (60cc total).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of uterine fibroids requiring surgical excision with preservation of the uterus
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Provision of signed and dated informed consent form

Exclusion Criteria

* Pre-existing diagnoses of anxiety or depression
* Pre-existing coagulopathies
* Pre-existing neuropathic or chronic pelvic pain
* Chronic opioid use
* Illiteracy due to inability to read and understand plain questionnaire
* Non-English speaking
* BMI \>38

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No