The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

Status unconfirmed · Not applicable

Conditions studied: Pelvic Floor Prolapse, Surgery, Pain, Postoperative

In brief

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 with bupivacaine or no injection (standard of care) as a part of their surgical pain control

Key facts

Study ID

NCT04428320

Run by

The Cooper Health System

People needed

140

Starts

2020-05-21

Expected to finish

2022-05-21

Last updated by the study team

2020-06-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Able to read English and give informed consent
• Undergoing VAGINAL pelvic reconstructive surgery for POP

You may not qualify if…

• 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

Where it is running

• Cooper Health University — Camden, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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