Skip to main content
Clinical Trials/NCT04428320
NCT04428320UnknownNot Applicable

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

The Cooper Health System2 sites in 1 country140 target enrollmentStarted: May 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
140
Locations
2
Primary Endpoint
VAS analog scale on post-op day #1

Study Overview

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

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).
  1. 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

VAS analog scale on post-op day #1

Time Frame: postop day #1

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials