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

NCT04198233 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-07-23

No results posted yet for this study

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

Interventions

DRUG

Diazepam

Diazepam 10 mg compounded suppository

DRUG

Placebos

Placebo suppository

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Rachel Pauls, MD · TriHealth - Cincinnati Urogynecology Associates

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-05-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198233 on ClinicalTrials.gov