QL Block in Laparoscopic Myomectomy

Phase 4

Not yet recruiting

• Conditions: Fibroid Uterus; Postoperative Pain
• Interventions: Drug: Saline; Drug: Bupivacain

• Registration Number: NCT05979493
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21
• Study Start: 2024-08-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
QL Block with Bupivacaine	Bupivacain	Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).

Primary Outcome Measures

Name	Time	Method
Total number of doses of rescue analgesics given as measured by medical chart review	Up to 24 hours
Time in minutes from first analgesic request as measured by medical chart review	Up to 24 hours

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with perioperative pain management measured on a scale of 1-10	Up to 48 hours after discharge from hospital.	Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.
Pain as measured by visual analog scale (VAS)	Up to 48 hours after discharge from hospital.	VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.

Trial Locations

Locations (1)

University Hospitals Ahuja Medical Center; 🇺🇸 Beachwood, Ohio, United States