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Completed Not applicable Interventional Results available

STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial

ClinicalTrials.gov ID: NCT04491617

Public ClinicalTrials.gov record NCT04491617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives have attempted to utilize restrictive opioid prescribing protocols for postoperative pain management in which patients were prescribed a limited number of opioid tablets (Hallway et al) or prescribed opioids only if they were used as an inpatient (Mark et al). These well-conducted studies show that restrictive opioid prescribing policies achieve the goal of reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction among patients. The objective of this study is to determine if a restrictive opioid prescription protocol (in which patients are not prescribed postoperative opioids unless they request them) is acceptable to patients after ambulatory and major urogynecologic surgery, compared to standard opioid prescribing practices. The study investigators believe that physicians can capitalize on the new ability to electronically prescribe opioids for patients who require them, to prevent over-prescribing without impacting patient care. The study also intends to describe postoperative opioid use patterns in the urogynecologic population, including factors predictive of opioid use and non-use. The results of this research will have a significant and timely impact by helping to reduce opioid overprescribing and informing future prescribing guidelines in the field of urogynecology.

Study identification

NCT ID
NCT04491617
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
The Cleveland Clinic
Other
Enrollment
129 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2020
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update posted
Jan 23, 2025

2020 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cleveland Clinic Cleveland Ohio 44195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04491617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 23, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04491617 live on ClinicalTrials.gov.

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