NCT04198233

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

Impact of Placement of a Diazepam Suppository Intraoperatively on Early Postoperative Pain Following Pelvic Reconstructive Surgery: a Double-Blind, Randomized Placebo-Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hysterectomy is the most common major surgery performed in gynecology. Minimally invasive techniques for hysterectomy including vaginal and laparoscopic routes are preferred over the more invasive abdominal procedures, which are associated with more pain, longer hospital stays, and increased rates of complications. Research has continued to provide evidence that same day discharge (SDD) after hysterectomy is safe, cost effective, and well received by patients. Pain is a common concern for patients undergoing major pelvic surgery and pain must be well controlled prior to discharge home. Rectal administrations of medications are an attractive option postoperatively in patients desiring SDD. Rectal analgesia avoids 1st pass metabolism in the liver, leading to increased bioavailability of many medications and fewer side effects such as nausea and vomiting. The purpose of the study is to investigate whether perioperative administration of a rectally administered diazepam suppository results in improved pain scores between 3.5 and 6 hours postoperatively in patients undergoing major vaginal pelvic reconstructive surgery.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Diazepam	Diazepam 10 mg compounded suppository
DRUG	Placebos	Placebo suppository

Timeline

• Start date: 2020-02-12
• Primary completion: 2022-05-01
• Completion: 2022-12-01
• First posted: 2019-12-13
• Last updated: 2020-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study