QL Block in Laparoscopic Myomectomy

Joseph Findley MD

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain; Fibroid Uterus

Treatments: Drug: Bupivacain; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05979493

STUDY20230830

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

QL Block with Bupivacaine

Experimental group

Description:

Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).

Treatment:

Drug: Bupivacain

Control

Sham Comparator group

Description:

Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).

Treatment:

Drug: Saline