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NCT05979493 | RECRUITING | Postoperative Pain

QL Block in Laparoscopic Myomectomy
Sponsor:

Joseph Findley MD

Information provided by (Responsible Party):

Joseph Findley MD

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.

Condition or disease

Postoperative Pain

Fibroid Uterus

Intervention/treatment

Bupivacain

Saline

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : TRIPLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
Actual Study Start Date : 2024-08-24
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-07-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
QL Block in Laparoscopic Myomectomy

Location Details

NCT05979493

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

University Hospitals Ahuja Medical Center

Beachwood, Ohio, United States, 44122