NCT04198233

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 23, 2020

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

December 11, 2019

Last Update Submit

July 21, 2020

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Vaginal/Rectal pain in Visual Analogue Scale (VAS) score

    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

Study Arms (2)

Diazepam group

EXPERIMENTAL

Rectal Diazepam suppository

Drug: Diazepam

Placebo group

PLACEBO COMPARATOR

Placebo suppository

Drug: Placebos

Interventions

DiazepamDRUG

Diazepam 10 mg compounded suppository

Diazepam group
PlacebosDRUG

Placebo suppository

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, 45220, United States

RECRUITING

Related Publications (1)

  • Aldrich ER, Tam TY, Saylor LM, Crisp CC, Yeung J, Pauls RN. Intrarectal diazepam following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial. Am J Obstet Gynecol. 2022 Aug;227(2):302.e1-302.e9. doi: 10.1016/j.ajog.2022.05.009. Epub 2022 May 10.

    PMID: 35550374DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rachel Pauls, MD

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunsun Yook, MS

CONTACT

513-463-4300eunsun_yook@trihealth.com

Emily Aldrich, MD

CONTACT

513-463-4300Emily_Aldrich@trihealth.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
All surgeons, patients and research staff will be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

February 12, 2020

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

July 23, 2020

Record last verified: 2019-12

Locations

US(1)