STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial (STOP-PAIN)

January 22, 2025 updated by: The Cleveland Clinic

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 satisfaction will be non-inferior between patients not routinely prescribed opioids after surgery and those prescribed a standard quantity. Participants will be asked to rate their pain control during the first 7 postoperative days with validated questionnaires. Participants' satisfaction with pain control will be evaluated at their postoperative visit.

Aim 2. To examine opioid use patterns after ambulatory and major urogynecologic surgery.

The study investigators hypothesize that most postoperative patients will use few or no opioids after urogynecologic surgery, regardless of prescribing protocol. All participants will receive thorough counseling with detailed instructions on non-opioid pain management, as well as multimodal analgesia via ERAS protocol during the perioperative period. Participants will be asked to log their opioid and non-opioid medication use in the first postoperative week. The investigators will also assess the number of requests for opioid prescription (in those randomized to the restrictive protocol) and opioid refills (from patients in the standard protocol).

Aim 3. To determine patient and perioperative factors associated with opioid use after urogynecologic surgery.

The study investigators plan to collect and analyze demographic, clinical and psychometric data on all participants with the goal of predicting analgesic needs and opioid use after urogynecologic surgery. Results from this study will guide surgeons on how to tailor opioid prescriptions to the needs of each patient, based off individual patient and perioperative characteristics.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Opioid Protocol (Control)
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Other: Standard opioid prescribing
Patients are routinely prescribed opioid medications in addition to non-opioids.
Experimental: Restrictive Opioid Protocol (Intervention)
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Other: Restrictive opioid prescribing
Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit
Time Frame: 6-weeks
The proportion of patients satisfied with postoperative pain control will be reported. Patient satisfaction with pain control was assessed with a 5-point Likert scale at the postoperative visit ("Overall, how satisfied were you with your postoperative pain medication?" [ranked 1- Very Dissatisfied to 5- Very Satisfied] and those who ranked their satisfaction level as a 4 or 5 were considered satisfied.
6-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level Scores During First Postoperative Week
Time Frame: 1-week
Patients will be asked to report their pain level for the first 7 days postoperatively. Pain levels will be assessed using questions 1, 2 and 4 from the Modified Surgical Pain Scales (SPS), which measures pain at rest, during normal activities and quantifies unpleasantness of worst pain using an 11-point numeric rating score, with 0 representing 'No pain sensation' and 10 representing 'Most intense pain imaginable'. Higher scores indicate a greater amount of pain. REDCap or paper surveys will be used.
1-week
Opioid Usage in the First Postoperative Week
Time Frame: 1-week
Participants will be asked to log opioid and non-opioid medication in number of tablets used during the first postoperative week with either REDCap or paper surveys. The opioid usage by study arm was reported in mean morphine equivalents (MMEs).
1-week
Number of Participants Who Requested a New Opioid Prescription or Opioid Refill
Time Frame: 6-weeks
Investigators will track the number of participants who requested a new opioid prescription or opioid refill during the 6 week postoperative period.
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Cecile A Ferrando, M.D., M.P.H., The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-682

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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