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

July 21, 2020 updated by: TriHealth Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diazepam group
Rectal Diazepam suppository
Drug: Diazepam
Diazepam 10 mg compounded suppository
PLACEBO_COMPARATOR: Placebo group
Placebo suppository
Drug: Placebos
Placebo suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal/Rectal pain in Visual Analogue Scale (VAS) score
Time Frame: 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.
between 3.5 and 6 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2020

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (ACTUAL)

December 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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