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

Sponsor

The Cooper Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT04428320

Collaborator

(none)

140

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Prolapse Surgery Pain, Postoperative	Procedure: Pelvic floor injection	N/A

Detailed Description

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:

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).

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

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Control TrialRandomized Control Trial

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 21, 2020

Anticipated Primary Completion Date :

May 21, 2022

Anticipated Study Completion Date :

May 21, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

VAS analog scale on post-op day #1 [postop day #1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cooper Health University	Camden	New Jersey	United States	08105

Sponsors and Collaborators

The Cooper Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cooper Health System

ClinicalTrials.gov Identifier:

NCT04428320

Other Study ID Numbers:

19-124

First Posted:

Jun 11, 2020

Last Update Posted:

Jun 11, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prolapse

Pain, Postoperative

Study Results

No Results Posted as of Jun 11, 2020