Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Sponsor

David Sheyn (Other)

Overall Status

Recruiting

CT.gov ID

NCT05571072

Collaborator

(none)

118

Enrollment

Location

Arms

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Opioid Use Prolapse Genital	Other: Opioid calculator Other: Standard opioid prescription	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Actual Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: Standard opioid prescription Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.
Experimental: Opioid Calculator Prescription Patients will be a given a prescription for opioid pain medication based on the opioid calculator.	Other: Opioid calculator Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.

Arm

Intervention/Treatment

Active Comparator: 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.

Other: Standard opioid prescription

Patients will receive prescription for post-operative opioids based on what the attending surgeon usually provides.

Experimental: Opioid Calculator Prescription

Patients will be a given a prescription for opioid pain medication based on the opioid calculator.

Other: Opioid calculator

Our research group previously created an Opioid calculator that can be used to predict the number of opioids needed post-operatively based on patient health history and characteristics.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

David Sheyn

Investigators

Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Sheyn, Associate Professor of Urology, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT05571072

Other Study ID Numbers:

STUDY20221287

First Posted:

Oct 7, 2022

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Sheyn, Associate Professor of Urology, University Hospitals Cleveland Medical Center

post operative pain

opioid use

urogynecologic surgery

Additional relevant MeSH terms:

Prolapse

Pain, Postoperative

Analgesics, Opioid

Study Results

No Results Posted as of Jan 18, 2023