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N/A N=129 Randomized Treatment

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

Postoperative Pain · Opioid Use · Prolapse; Female · Incontinence

Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit — 59; 58 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard opioid prescribing (Other); Restrictive opioid prescribing (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
The Cleveland Clinic
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit
59; 58
SECONDARY
Pain Level Scores During First Postoperative Week
7; 6; 6; 5; 5; 4
SECONDARY
Opioid Usage in the First Postoperative Week
0; 0
SECONDARY
Number of Participants Who Requested a New Opioid Prescription or Opioid Refill
6; 2

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 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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04491617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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