Back to resultsQL Block in Laparoscopic Myomectomy
Primary Purpose
Postoperative Pain, Fibroid Uterus
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacain
Saline
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring QL Block, Myomectomy
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
Sites / Locations
- University Hospitals Ahuja Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
QL Block with Bupivacaine
Control
Arm Description
Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
Outcomes
Primary Outcome Measures
Time in minutes from first analgesic request as measured by medical chart review
Total number of doses of rescue analgesics given as measured by medical chart review
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979493
Brief Title
QL Block in Laparoscopic Myomectomy
Official Title
Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Findley MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Fibroid Uterus
Keywords
QL Block, Myomectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL Block with Bupivacaine
Arm Type
Experimental
Arm Description
Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
30cc IM injection in each quadratus lumborum muscle (60cc total).
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
30cc IM injection in each quadratus lumborum muscle (60cc total).
Primary Outcome Measure Information:
Title
Time in minutes from first analgesic request as measured by medical chart review
Time Frame
Up to 24 hours
Title
Total number of doses of rescue analgesics given as measured by medical chart review
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Pain as measured by visual analog scale (VAS)
Description
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.
Title
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Description
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 Pre-specified Outcome Measures:
Title
Pain as measured by Richmond Agitation Sedation Scale (RASS)
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine P Haering, BA
Phone
3392011531
Email
cph43@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Findley, MD
Organizational Affiliation
University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Ahuja Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine P Haering, BA
Phone
339-201-1531
Email
cph43@case.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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QL Block in Laparoscopic Myomectomy
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