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

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: Placebos; Drug: Diazepam

• Registration Number: NCT04198233
• Lead Sponsor: TriHealth Inc.

Brief 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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-02-12
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23
• Primary Completion: 2022-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebos	Placebo suppository
Diazepam group	Diazepam	Rectal Diazepam suppository

Primary Outcome Measures

Name	Time	Method
Vaginal/Rectal pain in Visual Analogue Scale (VAS) score	between 3.5 and 6 hours postoperatively	VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects draw a vertical line on the scale corresponding to their pain level.

Trial Locations

Locations (1)

Trihealth (Good Samaritan Hospital, Bethesda North Hospital); 🇺🇸 Cincinnati, Ohio, United States