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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428320
• Other study ID #: 19-124
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: May 21, 2022

Study information

• Verified date: June 2020
• Source: The Cooper Health System
• Contact: Lioudmila Lipetskaia, MD
• Phone: 610-462-608
• Email: lipetskaia-lioudmila[@]cooperhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 21, 2022
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Pelvic Floor Prolapse
• Prolapse
• Surgery

Intervention

Procedure:
• Pelvic floor injection
Injection of 10 cc of bupivacaine

Locations

Country	Name	City	State
United States	Cooper Health University	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS analog scale on post-op day #1		postop day #1