QL Block in Laparoscopic Myomectomy

Part of paid clinical trials in Beachwood, Ohio.

Sponsor
Joseph Findley MD
Study ID
NCT05979493
Phase
PHASE4
Status
Recruiting
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Conditions

  • Fibroid Uterus
  • Postoperative Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Bupivacain — DRUG
    30cc IM injection in each quadratus lumborum muscle (60cc total).
  • Saline — DRUG
    30cc IM injection in each quadratus lumborum muscle (60cc total).

Study Details

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.

Key Dates

Start date
Aug 24, 2024
Status verified
Jul 2025
Primary completion
Jul 1, 2026
Completion
Jul 3, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: QL Block with Bupivacaine
    Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
  • Sham Comparator: Control
    Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).

Primary Outcome Measure

Time in minutes from first analgesic request as measured by medical chart review [ Time Frame: Up to 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Ahuja Medical CenterBeachwoodOhio44122
Catherine P Haering, BA
[email protected]
3392011531

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By research site
University Hospitals Ahuja Medical Center· Beachwood, OH

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