QL Block in Laparoscopic Myomectomy

Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Fibroid Uterus
• Intervention / Treatment: Drug: Bupivacain; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Catherine P Haering, BA; Phone Number: 3392011531; Email: cph43@case.edu

Study Locations

• United States
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • University Hospitals Ahuja Medical Center
      • Contact: Catherine P Haering, BA; Phone Number: 3392011531; Email: cph43@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 hours after discharge from hospital.
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.	Up to 48 hours after discharge from hospital.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 24 hours

Collaborators and Investigators

• Sponsor: Joseph Findley MD
• Investigators: Principal Investigator: Joseph Findley, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 3, 2026

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Myomectomy; QL Block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Pain, Postoperative; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: STUDY20230830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No