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

Last updated: June 9, 2020
Sponsor: The Cooper Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

N/A

Clinical Study ID

NCT04428320
19-124
  • Ages > 18
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Able to read English and give informed consent

  • Undergoing VAGINAL pelvic reconstructive surgery for POP

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 140
Study Start date:
May 21, 2020
Estimated Completion Date:
May 21, 2022

Study 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.

Connect with a study center

  • Cooper Health University

    Camden, New Jersey 08105
    United States

    Active - Recruiting

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