Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

D

David Sheyn

Status

Active, not recruiting

Conditions

Prolapse Genital
Opioid Use
Post Operative Pain

Treatments

Other: Standard opioid prescription
Other: Opioid calculator

Study type

Interventional

Funder types

Other

Identifiers

NCT05571072
STUDY20221287

Details and patient eligibility

About

The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.

Enrollment

110 patients

Sex

Female

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18-89
  • Able to provide informed consent
  • Patients undergoing any of below urogynecologic procedures

Included urogynecologic procedures:

Sacrocolpopexy - robotic or laparoscopic

  • With or without hysterectomy
  • With or without salpingo-oophorectomy
  • With or without anterior colporrhaphy
  • With or without posterior colporrhaphy/perineorrhaphy
  • With or without midurethral sling

Sacrospinous ligament fixation

  • With or without hysterectomy
  • With or without salpingo-oophorectomy
  • With or without anterior colporrhaphy
  • With or without posterior colporrhaphy/perineorrhaphy
  • With or without midurethral sling

Uterosacral ligament suspension - robotic, laparoscopic, or vaginal

  • With or without hysterectomy
  • With or without salpingo-oophorectomy
  • With or without anterior colporrhaphy
  • With or without posterior colporrhaphy/perineorrhaphy
  • With or without midurethral sling

Colpocleisis

  • Lefort colpocleisis
  • Complete colpectomy with colpocleisis
  • Isolated anterior and/or posterior colporrhaphy

Exclusion criteria

  • Non-English speakers
  • pre-operative diagnosis of cancer
  • scheduled for any concurrent non-urogynecologic procedure (ex: abdominoplasty)
  • <18 years or >89 years of age
  • unable to provide informed consent

Trial design

110 participants in 2 patient groups

Standard Opioid Prescription
Active Comparator group
Description:
Patients will be given a prescription for opioid pain medication to use for acute postoperative pain as would be typical for the attending surgeon performing the surgery.
Treatment:
Other: Standard opioid prescription
Opioid Calculator Prescription
Experimental group
Description:
Patients will be a given a prescription for opioid pain medication based on the opioid calculator.
Treatment:
Other: Opioid calculator

Trial contacts and locations

0

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Central trial contact

Hope Bauer, MD; David Sheyn, MD

Data sourced from clinicaltrials.gov

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