Status:
UNKNOWN
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
Lead Sponsor:
The Cooper Health System
Conditions:
Pelvic Floor Prolapse
Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections ...
Detailed Description
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive: 1. Bilateral trans- vaginal pelvic floor levator ani ...
Eligibility Criteria
Inclusion
- Female
- Able to read English and give informed consent
- Undergoing VAGINAL pelvic reconstructive surgery for POP
Exclusion
- Hypersensitivity or allergy to amide anesthetics
- Documented chronic pain condition
- o (back pain, pelvic pain, fibromyalgia, etc.)
- Bleeding disorder
- Connective tissue disorder
- Neuromuscular disorder
- Cardiac conduction abnormality or channelopathy
- Hepatic Impairment
- Renal Impairment
- History of, or current, narcotic or alcohol dependence
- History of pelvic radiation or gynecologic malignancy
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 21 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04428320
Start Date
May 21 2020
End Date
May 21 2022
Last Update
June 11 2020
Active Locations (1)
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1
Cooper Health University
Camden, New Jersey, United States, 08105