Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

David Sheyn1 site in 1 country110 target enrollmentJanuary 2, 2023

ConditionsPost Operative Pain Opioid Use Prolapse Genital

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post Operative Pain
Sponsor: David Sheyn
Enrollment: 110
Locations: 1
Primary Endpoint: Change in pain scores measured by team-created pain questionnaires
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2, 2023

End Date

February 17, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

David Sheyn

Responsible Party

Sponsor Investigator

Principal Investigator

David Sheyn

Associate Professor of Urology

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Change in pain scores measured by team-created pain questionnaires

Time Frame: 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 Outcomes

Change in satisfaction scores measured by team-created questionnaire(1 week post-op, 2 weeks post-op)
Change in number of opioid tablets remaining measured by team-created questionnaire(1 week post-op, 2 weeks post-op)