Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

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

Recruiting Locations

University Hospitals Ahuja Medical Center
Beachwood, Ohio 44122
Contact:
Catherine P Haering, BA
3392011531
cph43@case.edu

More Details

NCT ID
NCT05979493
Status
Recruiting
Sponsor
Joseph Findley MD

Study Contact

Catherine P Haering, BA
3392011531
cph43@case.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.