Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6 hours postoperative compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Diazepam

Criteria

Inclusion Criteria:

• English speaking, able to understand informed consent and questionnaires

• Vaginal hysterectomy with vaginal vault suspension by one of the providers in the Division of Urogynecology and Reconstructive Pelvic Surgery at TriHealth, Inc.

• With or without anterior and posterior repairs

• With or without concomitant procedure for stress urinary incontinence

• With or without removal of fallopian tubes or ovaries

Exclusion Criteria:

• Use of mesh for prolapse repair

• Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy

• Concomitant procedure done by an additional surgeon

• Concomitant anal sphincteroplasty or rectovaginal fistula repair

• Contraindication to use of Diazepam:

• Allergy to Diazepam or other benzodiazepines

• Acute narrow-angle glaucoma

• Untreated open-angle glaucoma

• Myasthenia gravis

• Severe respiratory impairment

• Severe hepatic impairment

• History of chronic pelvic pain receiving medical care

• Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline

• Pregnancy