QL Block in Laparoscopic Myomectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979493
• Other study ID #: STUDY20230830
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 31, 2024
• Est. completion date: January 3, 2025

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Catherine P Haering, BA
• Phone: 3392011531
• Email: cph43[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 3, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacain
30cc IM injection in each quadratus lumborum muscle (60cc total).
• Saline
30cc IM injection in each quadratus lumborum muscle (60cc total).

Locations

Country	Name	City	State
United States	University Hospitals Ahuja Medical Center	Beachwood	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joseph Findley MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Time in minutes from first analgesic request as measured by medical chart review		Up to 24 hours
Primary	Total number of doses of rescue analgesics given as measured by medical chart review		Up to 24 hours
Secondary	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.
Secondary	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.