QL Block in Laparoscopic Myomectomy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJoseph Findley MD

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-existing diagnoses of anxiety or depression

Pre-existing coagulopathies

Pre-existing neuropathic or chronic pelvic pain

Chronic opioid use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacain

    Drug

    30cc IM injection in each quadratus lumborum muscle (60cc total).

  • Saline

    Drug

    30cc IM injection in each quadratus lumborum muscle (60cc total).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: QL Block with BupivacaineExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time in minutes from first analgesic request as measured by medical chart review

Time frame
Up to 24 hours
2

Total number of doses of rescue analgesics given as measured by medical chart review

Time frame
Up to 24 hours

Secondary outcomes

1

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.

Time frame
Up to 48 hours after discharge from hospital.
2

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.

Time frame
Up to 48 hours after discharge from hospital.

Other outcomes

1

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

Time frame
Up to 24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joseph Findley MD

Lead sponsor

University Hospitals Cleveland Medical Center

Sponsor institution