Fibroid Uterus, Postoperative Pain
Conditions
Keywords
QL Block, Myomectomy
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.
Interventions
DRUGBupivacain
30cc IM injection in each quadratus lumborum muscle (60cc total).
DRUGSaline
30cc IM injection in each quadratus lumborum muscle (60cc total).
Sponsors
Joseph Findley MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain as measured by visual analog scale (VAS) | Up to 48 hours after discharge from hospital. | VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever. |
| Patient satisfaction with perioperative pain management measured on a scale of 1-10 | Up to 48 hours after discharge from hospital. | Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment. |
Countries
United States
Contacts
CONTACTCatherine P Haering, BA
PRINCIPAL_INVESTIGATORJoseph Findley, MD
University Hospitals
Outcome results
None listed