Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
Overview
- Phase
- Phase 4
- Intervention
- Bupivacain
- Conditions
- Postoperative Pain
- Sponsor
- Joseph Findley MD
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Total number of doses of rescue analgesics given as measured by medical chart review
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Joseph Findley MD
University Hospitals Department of Reproductive Endocrinology and Infertility
University Hospitals Cleveland Medical Center
Eligibility 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
Arms & Interventions
QL Block with Bupivacaine
Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
Intervention: Bupivacain
Control
Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
Intervention: Saline
Outcomes
Primary Outcomes
Total number of doses of rescue analgesics given as measured by medical chart review
Time Frame: Up to 24 hours
Time in minutes from first analgesic request as measured by medical chart review
Time Frame: Up to 24 hours
Secondary Outcomes
- Patient satisfaction with perioperative pain management measured on a scale of 1-10(Up to 48 hours after discharge from hospital.)
- Pain as measured by visual analog scale (VAS)(Up to 48 hours after discharge from hospital.)