QL Block in Laparoscopic Myomectomy

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Pain, Fibroid Uterus

Intervention / Treatment
-----------------
* Drug: Bupivacain
* Drug: Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL Block with Bupivacaine<br>Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total). | Drug: Bupivacain<br>* 30cc IM injection in each quadratus lumborum muscle (60cc total).<br>|
| Sham Comparator: Control<br>Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total). | Drug: Saline<br>* 30cc IM injection in each quadratus lumborum muscle (60cc total).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 48 hours after discharge from hospital. | 
| 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. | Up to 48 hours after discharge from hospital. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QL Block, Myomectomy