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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04491617
Acronym
STOP-PAIN
Enrollment
129
Registered
2020-07-29
Start date
2020-08-27
Completion date
2022-08-31
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Opioid Use, Postoperative Pain, Prolapse; Female

Keywords

Opioids, Gynecology, Pain control, Prolapse, Incontinence

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 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.

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.

Interventions

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

OTHERRestrictive opioid prescribing

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

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit6-weeksThe 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

MeasureTime frameDescription
Pain Level Scores During First Postoperative Week1-weekPatients 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.
Opioid Usage in the First Postoperative Week1-weekParticipants 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).
Number of Participants Who Requested a New Opioid Prescription or Opioid Refill6-weeksInvestigators will track the number of participants who requested a new opioid prescription or opioid refill during the 6 week postoperative period.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Opioid Protocol (Control)
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
64
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 Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
63
Total127

Baseline characteristics

CharacteristicRestrictive Opioid Protocol (Intervention)TotalStandard Opioid Protocol (Control)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
16 Participants35 Participants19 Participants
Age, Categorical
Between 18 and 65 years
47 Participants92 Participants45 Participants
Age, Continuous55.9 years56.3 years56.7 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants5 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
63 Participants122 Participants59 Participants
Region of Enrollment
United States
63 participants127 participants64 participants
Sex: Female, Male
Female
63 Participants127 Participants64 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 640 / 63
other
Total, other adverse events
0 / 640 / 63
serious
Total, serious adverse events
0 / 640 / 63

Outcome results

Primary

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

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.

Time frame: 6-weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Opioid Protocol (Control)Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit59 Participants
Restrictive Opioid Protocol (Intervention)Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit58 Participants
Secondary

Number of Participants Who Requested a New Opioid Prescription or Opioid Refill

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

Time frame: 6-weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard Opioid Protocol (Control)Number of Participants Who Requested a New Opioid Prescription or Opioid Refill6 Participants
Restrictive Opioid Protocol (Intervention)Number of Participants Who Requested a New Opioid Prescription or Opioid Refill2 Participants
Secondary

Opioid Usage in the First Postoperative 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).

Time frame: 1-week

ArmMeasureValue (MEDIAN)
Standard Opioid Protocol (Control)Opioid Usage in the First Postoperative Week0 MMEs
Restrictive Opioid Protocol (Intervention)Opioid Usage in the First Postoperative Week0 MMEs
Secondary

Pain Level Scores During First Postoperative 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.

Time frame: 1-week

ArmMeasureGroupValue (MEDIAN)
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 72 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 17 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 35 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 44 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 53 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 63 score on a scale
Standard Opioid Protocol (Control)Pain Level Scores During First Postoperative WeekDay 26 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 53 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 72 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 44 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 16 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 25 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 63 score on a scale
Restrictive Opioid Protocol (Intervention)Pain Level Scores During First Postoperative WeekDay 34 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026