Recruiting

Diazepam

Sponsor:

TriHealth Inc.

Code:

NCT04198233

Conditions

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Diazepam

Placebos

Study Details

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.

Conditions

Postoperative Pain

Study ID

NCT04198233

Start date

Feb 12, 2020

Status verified date

Dec, 2019

Completion date

Dec, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Diazepam group

Rectal Diazepam suppository

placebo comparator: Placebo group

Placebo suppository

Interventions

Diazepam

Diazepam 10 mg compounded suppository

Placebos

Placebo suppository

Primary outcome measure

  • Vaginal/Rectal pain in Visual Analogue Scale (VAS) score [ Time Frame: between 3.5 and 6 hours postoperatively ]

Central Contacts and Locations

Central contacts

Eunsun Yook, MS

513-463-4300eunsun_yook@trihealth.com

Emily Aldrich, MD

513-463-4300Emily_Aldrich@trihealth.com

Locations

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Emily Aldrich, MD

Emily_Aldrich@trihealth.com

Rachedl Pauls, MD

Rachel_Pauls@trihealth.com

More Information

Sponsor

TriHealth Inc.

Last update posted

Jul 23, 2020

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TriHealth Inc. on 2020-07-23.