Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

David Sheyn

Status: Completed

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:

1. Sacrocolpopexy - robotic or laparoscopic

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling

2. Sacrospinous ligament fixation

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling

3. Uterosacral ligament suspension - robotic, laparoscopic, or vaginal

   1. With or without hysterectomy
   2. With or without salpingo-oophorectomy
   3. With or without anterior colporrhaphy
   4. With or without posterior colporrhaphy/perineorrhaphy
   5. With or without midurethral sling

4. Colpocleisis

   1. Lefort colpocleisis
   2. Complete colpectomy with colpocleisis

5. 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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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