QL Block in Laparoscopic Myomectomy

NCT05979493 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY20230830
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Fibroid Uterus

Keywords

QL Block; Myomectomy

Outcome Measures

Primary Outcomes (2)

• Time in minutes from first analgesic request as measured by medical chart review

  Up to 24 hours

• Total number of doses of rescue analgesics given as measured by medical chart review

  Up to 24 hours

Secondary Outcomes (2)

• Pain as measured by visual analog scale (VAS)

  Up to 48 hours after discharge from hospital.

• Patient satisfaction with perioperative pain management measured on a scale of 1-10

  Up to 48 hours after discharge from hospital.

Other Outcomes (1)

• Pain as measured by Richmond Agitation Sedation Scale (RASS)

  Up to 24 hours

Study Arms (2)

QL Block with Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacain

Control

SHAM COMPARATOR

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

Drug: Saline

Interventions

Bupivacain DRUG

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

QL Block with Bupivacaine

Saline DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Findley MD: lead

Study Sites (1)

University Hospitals Ahuja Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Leiomyoma

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joseph Findley, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine P Haering, BA

CONTACT

3392011531; cph43@case.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Hospitals Department of Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: August 24, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 3, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)