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

TriHealth

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Placebos; Drug: Diazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT04198233

19-130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

Diazepam group

Experimental group

Description:

Rectal Diazepam suppository

Treatment:

Drug: Diazepam

Placebo group

Placebo Comparator group

Description:

Placebo suppository

Treatment:

Drug: Placebos