QL Block in Laparoscopic Myomectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacain, Saline.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Fibroid Uterus. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
Overview
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.
Interventions
- Drug Bupivacain
30cc IM injection in each quadratus lumborum muscle (60cc total). - Drug Saline
30cc IM injection in each quadratus lumborum muscle (60cc total).
Primary outcome measures
- Time in minutes from first analgesic request as measured by medical chart review [Time frame: Up to 24 hours]
- Total number of doses of rescue analgesics given as measured by medical chart review [Time frame: Up to 24 hours]
Secondary outcome measures (2)
- Pain as measured by visual analog scale (VAS) [Time frame: Up to 48 hours after discharge from hospital.]
- Patient satisfaction with perioperative pain management measured on a scale of 1-10 [Time frame: Up to 48 hours after discharge from hospital.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University Hospitals Ahuja Medical Center — Beachwood
Identifiers
NCT: NCT05979493 · STUDY20230830