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NCT Number: NCT05979493

QL Block in Laparoscopic Myomectomy

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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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Ahuja Medical Center

Beachwood, Ohio, 44122, United States

Location status: Recruiting

Location contact

Catherine P Haering, BA

CONTACT

[email protected]

3392011531

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bupivacain

Drug

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

Saline

Drug

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

Primary outcomes

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

    Time frame: Up to 24 hours

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

    Time frame: Up to 24 hours

Secondary outcomes

  1. Pain as measured by visual analog scale (VAS)

    Time frame: Up to 48 hours after discharge from hospital.

    VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.

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

    Time frame: Up to 48 hours after discharge from hospital.

    Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.

Other outcomes

  1. Pain as measured by Richmond Agitation Sedation Scale (RASS)

    Time frame: Up to 24 hours

    RASS is measured from -5 to +4 with -5 being no response to voice or physical stimulation and +4 being overtly combative, violent, immediate danger to staff

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine P Haering, BA

CONTACT

[email protected]

3392011531

Sponsors and collaborators

Lead sponsor

Joseph Findley MD

Other

Registry information

Official study title

Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Aug 6, 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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