Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Not Applicable

Completed

• Conditions: Post Operative Pain; Opioid Use; Prolapse Genital
• Interventions: Other: Standard opioid prescription; Other: Opioid calculator

• Registration Number: NCT05571072
• Lead Sponsor: David Sheyn

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2023-01-02
• Primary Completion: 2024-02-17
• Study Completion: 2024-02-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Opioid Prescription	Standard opioid prescription	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.
Opioid Calculator Prescription	Opioid calculator	Patients will be a given a prescription for opioid pain medication based on the opioid calculator.

Primary Outcome Measures

Name	Time	Method
Change in pain scores measured by team-created pain questionnaires	baseline, 1 week post-op, 2 weeks post-op	Pain questionnaire is a 2 question survey that ask patients to rate pain on scale of 0 (no pain) to 10 (worst pain) immediately post-op and current. Baseline will be calculated by asking patient's expected post-op pain score.

Secondary Outcome Measures

Name	Time	Method
Change in satisfaction scores measured by team-created questionnaire	1 week post-op, 2 weeks post-op	Questionnaire is a 1 question survey that ask patients to rate their satisfaction with their pain control on scale of 0 (totally unsatisfied) to 10 (totally satisfied) immediately post-op and current.
Change in number of opioid tablets remaining measured by team-created questionnaire	1 week post-op, 2 weeks post-op	Patients will be asked the number of tablets remaining from their opioid prescriptions.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States