NCT04428320

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Pelvic Floor Prolapse
• Surgery
• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Pelvic floor injection	Injection of 10 cc of bupivacaine

Timeline

• Start date: 2020-05-21
• Primary completion: 2022-05-21
• Completion: 2022-05-21
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: United States