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Trial Title:
QL Block in Laparoscopic Myomectomy
NCT ID:
NCT05979493
Condition:
Postoperative Pain
Fibroid Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Pain, Postoperative
Bupivacaine
Conditions: Keywords:
QL Block
Myomectomy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Bupivacain
Description:
30cc IM injection in each quadratus lumborum muscle (60cc total).
Arm group label:
QL Block with Bupivacaine
Intervention type:
Drug
Intervention name:
Saline
Description:
30cc IM injection in each quadratus lumborum muscle (60cc total).
Arm group label:
Control
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Ahuja Medical Center
Address:
City:
Beachwood
Zip:
44122
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine P Haering, BA
Phone:
3392011531
Email:
cph43@case.edu
Start date:
August 24, 2024
Completion date:
July 3, 2025
Lead sponsor:
Agency:
Joseph Findley MD
Agency class:
Other
Source:
University Hospitals Cleveland Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979493
