QL Block in Laparoscopic Myomectomy

Sponsor

Joseph Findley MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05979493

Collaborator

(none)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Fibroid Uterus	Drug: Bupivacain Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 3, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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.
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.

Other Outcome Measures

Pain as measured by Richmond Agitation Sedation Scale (RASS) [Up to 24 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Ahuja Medical Center	Beachwood	Ohio	United States	44122

Sponsors and Collaborators

Joseph Findley MD

Investigators

Principal Investigator: Joseph Findley, MD, University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Findley MD, University Hospitals Department of Reproductive Endocrinology and Infertility, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT05979493

Other Study ID Numbers:

STUDY20230830

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Joseph Findley MD, University Hospitals Department of Reproductive Endocrinology and Infertility, University Hospitals Cleveland Medical Center

QL Block

Myomectomy

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2023