About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pre-existing diagnoses of anxiety or depression
Pre-existing coagulopathies
Pre-existing neuropathic or chronic pelvic pain
Chronic opioid use
Trial design
Parallel
Treatments tested in this trial
Bupivacain
Drug30cc IM injection in each quadratus lumborum muscle (60cc total).
Saline
Drug30cc IM injection in each quadratus lumborum muscle (60cc total).
Treatment groups
Trial outcomes
Primary outcomes
Time in minutes from first analgesic request as measured by medical chart review
Total number of doses of rescue analgesics given as measured by medical chart review
Secondary outcomes
Pain as measured by visual analog scale (VAS)
VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.
Other outcomes
Pain as measured by Richmond Agitation Sedation Scale (RASS)
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joseph Findley MD
Lead sponsor
University Hospitals Cleveland Medical Center
Sponsor institution