Status:
COMPLETED
STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
Lead Sponsor:
The Cleveland Clinic
Conditions:
Postoperative Pain
Opioid Use
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 take...
Detailed Description
Specific Aims Aim 1. To compare patient satisfaction and pain control using two different opioid prescribing protocols. The study investigators hypothesize that postoperative pain control and satisf...
Eligibility Criteria
Inclusion
- Age greater than 18 years old
- Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
- Transportation to outpatient clinic or ability to access Virtual Care Visits
- Able to speak and read English
- Has decision-making capacity and able to provide consent for research participation
Exclusion
- History of substance abuse disorder
- Chronic opioid use
- Score greater than or equal to 30 on Pain Catastrophizing Scale
- Allergy (not intolerance) to greater than or equal to 2 opioids
- Contraindications to both NSAIDs and acetaminophen
- Surgery scheduled on Friday or before major federal holiday
- Patients undergoing concomitant colorectal procedures
- Patients with perioperative complication (such as iatrogenic bowel and bladder injury, hemorrhage, unanticipated laparotomy or ICU admission)
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04491617
Start Date
August 27 2020
End Date
August 31 2022
Last Update
January 24 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195