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

Cooper University Health Care

Status: Unknown

Conditions: Surgery; Pelvic Floor Prolapse; Pain, Postoperative

Treatments: Procedure: Pelvic floor injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04428320

19-124

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Bupivicaine pelvic floor muscle injection

Experimental group

Description:

Five injections at pre-specified locations at pelvic floor muscle bilaterally after induction of general anesthesia for vaginal pelvic prolapse surgery

Treatment:

Procedure: Pelvic floor injection

Standard of care (no injection) preoperatively

No Intervention group

Description:

No injection - standard analgesia