Postoperative PainSTOP-PAINNCT04491617
STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
A study testing Standard opioid prescribing and Restrictive opioid prescribing in people with Postoperative Pain and Opioid Use, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Opioid Use, Prolapse; Female
- What is being tested?
- Standard opioid prescribing and Restrictive opioid prescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Opioid Use, Prolapse; Female, Incontinence
- Being tested
- Standard opioid prescribing, Restrictive opioid prescribing
- Keywords
- Opioids, Gynecology, Pain control, Prolapse, Incontinence
- Medical subject headings
- Pain, Postoperative, Prolapse, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard opioid prescribingOther
Patients are routinely prescribed opioid medications in addition to non-opioids.
Restrictive opioid prescribingOther
Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
| Study group | Role | What they receive |
|---|---|---|
| Standard Opioid Protocol (Control) | Active comparator | Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery Receives: Other: Standard opioid prescribing |
| Restrictive Opioid Protocol (Intervention) | Experimental | 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 Receives: Other: Restrictive opioid prescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-weeks
Secondary outcomes (3)
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.
Measured: 1-week
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).
Measured: 1-week
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.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Aug 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecile A Ferrando, M.D., M.P.H., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491617
- Sponsor's protocol ID
- 20-682
- Acronym
- STOP-PAIN
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2020
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PubMed 27631771Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
PubMed 29238810Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
PubMed 31154092Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.
PubMed 30646274Davidson ERW, Paraiso MFR, Walters MD, Propst K, Ridgeway B, Yao M, Ferrando CA. A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair. Am J Obstet Gynecol. 2020 Oct;223(4):547.e1-547.e12. doi: 10.1016/j.ajog.2020.03.017. Epub 2020 Mar 19.
PubMed 32199926Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.
PubMed 22777367Yuan AS, Propst KA, Ross JH, Wallace SL, Paraiso MFR, Park AJ, Chapman GC, Ferrando CA. Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial. Am J Obstet Gynecol. 2024 Mar;230(3):340.e1-340.e13. doi: 10.1016/j.ajog.2023.10.027. Epub 2023 Oct 18.
PubMed 37863158
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04491617
- Acronym / sponsor ID
- STOP-PAIN / 20-682
- Conditions
- Postoperative Pain, Opioid Use, Prolapse; Female, Incontinence
- Keywords
- Opioids, Gynecology, Pain control, Prolapse, Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Opioid Protocol (Control) | Active comparator | Other: Standard opioid prescribingStandard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery |
| Restrictive Opioid Protocol (Intervention) | Experimental | Other: Restrictive opioid prescribingOnly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard opioid prescribingPatients are routinely prescribed opioid medications in addition to non-opioids. | Other | Standard Opioid Protocol (Control) |
| Restrictive opioid prescribingPatients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them. | Other | Restrictive Opioid Protocol (Intervention) |
Primary outcome
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.
3 secondary outcomes
Pain Level Scores During First Postoperative Week
Time frame: 1-week
Opioid Usage in the First Postoperative Week
Time frame: 1-week
Number of Participants Who Requested a New Opioid Prescription or Opioid Refill
Time frame: 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27631771Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Background: PubMed 29238810Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
- Background: PubMed 31154092Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
- Background: PubMed 30646274Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.
- Background: PubMed 32199926Davidson ERW, Paraiso MFR, Walters MD, Propst K, Ridgeway B, Yao M, Ferrando CA. A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair. Am J Obstet Gynecol. 2020 Oct;223(4):547.e1-547.e12. doi: 10.1016/j.ajog.2020.03.017. Epub 2020 Mar 19.
- Background: PubMed 22777367Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.
- Derived from this study: PubMed 37863158Yuan AS, Propst KA, Ross JH, Wallace SL, Paraiso MFR, Park AJ, Chapman GC, Ferrando CA. Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial. Am J Obstet Gynecol. 2024 Mar;230(3):340.e1-340.e13. doi: 10.1016/j.ajog.2023.10.027. Epub 2023 Oct 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecile A Ferrando, M.D., M.P.H. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard opioid prescribing and Restrictive opioid prescribing in people with Postoperative Pain and Opioid Use, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491617, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.