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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Surgery; Pelvic Floor Prolapse
• Intervention / Treatment: Procedure: Pelvic floor injection

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08105
      • Recruiting
      • Cooper Health University
      • Contact: Lioudmila Lipetskaia; Phone Number: 610-462-1608; Email: lipetskaia-lioudmila@cooperhealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

  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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivicaine pelvic floor muscle injection; Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery	Procedure: Pelvic floor injection; Injection of 10 cc of bupivacaine
No Intervention: Standard of care (no injection) preoperatively; No injection - standard analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS analog scale on post-op day #1	postop day #1

Collaborators and Investigators

• Sponsor: The Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Anticipated): May 21, 2022
• Study Completion (Anticipated): May 21, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse
• Other Study ID Numbers: 19-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No sharing planned as of now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No