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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Opioid Protocol (Control) | Active Comparator | Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard opioid prescribing | Other | Patients are routinely prescribed opioid medications in addition to non-opioids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecile A Ferrando, M.D., M.P.H. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27631771 | Background | 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. | |
| 29238810 | Background | Chen 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Restrictive Opioid Protocol (Intervention) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6-weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile Ferrando, M.D. | Cleveland Clinic | 216-444-0642 | ferranc2@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2021 | Sep 26, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2021 | Sep 26, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011391 | Prolapse |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Restrictive opioid prescribing | Other | Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them. |
|
| 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). | 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. | 6-weeks |
| 31154092 | Background | Hallway 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. |
| 30646274 | Background | Mark 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. |
| 32199926 | Background | Davidson 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. |
| 22777367 | Background | Barber 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. |
| 37863158 | Derived | Yuan 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 1-week |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | MMEs | 1-week |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6-weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | 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. | 0 | 63 | 0 | 63 | 0 | 63 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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