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NCT Number: NCT04491617

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

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Key information

Conditions

Postoperative Pain Agnosia Incontinence Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Prolapse Prolapse; Female Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard opioid prescribing

Other

Patients are routinely prescribed opioid medications in addition to non-opioids.

Restrictive opioid prescribing

Other

Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: STOP-PAIN

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2020
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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