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

  • STATUS
    Recruiting
  • participants needed
    140
  • sponsor
    The Cooper Health System
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Updated on 16 February 2024
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anesthesia
bupivacaine
analgesia
prolapse
anaesthesia

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

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 muscle injections (trigger point injections) with bupivacaine:
    • 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
  2. Control- No additional treatment (standard of care).

The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.

Details
Condition Surgery, Surgical aspects, Surgery, Postoperative pain, Pelvic Floor Prolapse
Age 18years - 100years
Treatment Pelvic floor injection
Clinical Study IdentifierNCT04428320
SponsorThe Cooper Health System
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Hypersensitivity or allergy to amide anesthetics
Documented chronic pain condition
(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
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