NCT04491617: STOP-PAIN

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

Completed NA Results posted Last updated 24 January 2025

What this trial tests

NA trial testing Standard opioid prescribing in Postoperative Pain in 129 participants. Completed in 31 August 2022.

Timeline

27 August 2020

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	129
Start date	27 August 2020
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Standard opioid prescribing — full drug profile →
• Restrictive opioid prescribing

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Opioid Use — all drugs for Opioid Use →
• Prolapse; Female — all drugs for Prolapse; Female →
• Incontinence — all drugs for Incontinence →

Sponsor

The Cleveland Clinic

Who can join

18 and older, female only, with Postoperative Pain or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit Primary · 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.

Group	Value	95% CI
Standard Opioid Protocol (Control)	59
Restrictive Opioid Protocol (Intervention)	58

Pain Level Scores During First Postoperative Week Secondary · 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.

Day 1

Group	Value	95% CI
Standard Opioid Protocol (Control)	7	4 – 8
Restrictive Opioid Protocol (Intervention)	6	3 – 8

Day 2

Group	Value	95% CI
Standard Opioid Protocol (Control)	6	3 – 8
Restrictive Opioid Protocol (Intervention)	5	3 – 8

Day 3

Group	Value	95% CI
Standard Opioid Protocol (Control)	5	3 – 7
Restrictive Opioid Protocol (Intervention)	4	2 – 7

Day 4

Group	Value	95% CI
Standard Opioid Protocol (Control)	4	2 – 6
Restrictive Opioid Protocol (Intervention)	4	2 – 6

Day 5

Group	Value	95% CI
Standard Opioid Protocol (Control)	3	2 – 6
Restrictive Opioid Protocol (Intervention)	3	2 – 6

Day 6

Group	Value	95% CI
Standard Opioid Protocol (Control)	3	1 – 5
Restrictive Opioid Protocol (Intervention)	3	1 – 4

Day 7

Group	Value	95% CI
Standard Opioid Protocol (Control)	2	1 – 4
Restrictive Opioid Protocol (Intervention)	2	1 – 4

Opioid Usage in the First Postoperative Week Secondary · 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).

Group	Value	95% CI
Standard Opioid Protocol (Control)	0	0 – 15
Restrictive Opioid Protocol (Intervention)	0	0 – 8

Number of Participants Who Requested a New Opioid Prescription or Opioid Refill Secondary · 6-weeks

Investigators will track the number of participants who requested a new opioid prescription or opioid refill during the 6 week postoperative period.

Group	Value	95% CI
Standard Opioid Protocol (Control)	6
Restrictive Opioid Protocol (Intervention)	2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.