Recruiting

Levator Ani Injections

Sponsor:

The Cooper Health System

Code:

NCT04428320

Conditions

Pelvic Floor Prolapse

Surgery

Pain, Postoperative

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic floor injection

Study Details

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

Conditions

Pelvic Floor Prolapse

Surgery

Pain, Postoperative

Study ID

NCT04428320

Start date

May 21, 2020

Status verified date

Jun, 2020

Completion date

May 21, 2022

Anticipated

Primary completion date

May 21, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

no intervention: Standard of care (no injection) preoperatively

No injection - standard analgesia

Interventions

Pelvic floor injection

Injection of 10 cc of bupivacaine

Primary outcome measure

  • VAS analog scale on post-op day #1 [ Time Frame: postop day #1 ]

Central Contacts and Locations

Central contacts

Lioudmila Lipetskaia, MD

610-462-608lipetskaia-lioudmila@cooperhealth.edu

Devon Smith, MD

smith-devon@cooperhealth.edu

Locations

Cooper Health University

Recruiting

Camden, New Jersey, United States, 08105

Contacts

Lioudmila Lipetskaia

610-462-1608lipetskaia-lioudmila@cooperhealth.edu

More Information

Sponsor

The Cooper Health System

Last update posted

Jun 11, 2020

Last verified

Jun, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2020-06-11.