Status:

UNKNOWN

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

Lead Sponsor:

The Cooper Health System

Conditions:

Pelvic Floor Prolapse

Surgery

Eligibility:

FEMALE

18+ years

Phase:

NA

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 ...

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

May 21 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 21 2022

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT04428320

Start Date

May 21 2020

End Date

May 21 2022

Last Update

June 11 2020

Active Locations (1)

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1

Cooper Health University

Camden, New Jersey, United States, 08105