An interventional study of Standard opioid prescribing and Restrictive opioid prescribing in Postoperative Pain, Opioid Use and Prolapse; Female, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Other: Standard opioid prescribing
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
Other: Restrictive opioid prescribing
Patients are routinely prescribed opioid medications in addition to non-opioids.
Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
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
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
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
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
| Milestone | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) |
|---|---|---|
| Started | 64 | 65 |
| Completed | 64 | 63 |
| Not completed | 0 | 2 |
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.
| Participants | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) |
|---|---|---|
| Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit | 59 | 58 |
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.
| score on a scale | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) |
|---|---|---|
| Day 1 | 7 (4 to 8) | 6 (3 to 8) |
| Day 2 | 6 (3 to 8) | 5 (3 to 8) |
| Day 3 | 5 (3 to 7) | 4 (2 to 7) |
| Day 4 | 4 (2 to 6) | 4 (2 to 6) |
| Day 5 | 3 (2 to 6) | 3 (2 to 6) |
| Day 6 | 3 (1 to 5) | 3 (1 to 4) |
| Day 7 | 2 (1 to 4) | 2 (1 to 4) |
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).
| MMEs | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) |
|---|---|---|
| Opioid Usage in the First Postoperative Week | 0 (0 to 15) | 0 (0 to 8) |
Investigators will track the number of participants who requested a new opioid prescription or opioid refill during the 6 week postoperative period.
| Participants | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) |
|---|---|---|
| Number of Participants Who Requested a New Opioid Prescription or Opioid Refill | 6 | 2 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Opioid Protocol (Control) | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Restrictive Opioid Protocol (Intervention) | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Age, Categorical(Participants) | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 47 | 92 |
| >=65 years | 19 | 16 | 35 |
| Age, Continuous(years) | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) | Total |
|---|---|---|---|
| Mean | 56.7 (31 to 85) | 55.9 (26 to 73) | 56.3 (26 to 85) |
| Sex: Female, Male(Participants) | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) | Total |
|---|---|---|---|
| Female | 64 | 63 | 127 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 0 | 5 |
| White | 59 | 63 | 122 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Opioid Protocol (Control) | Restrictive Opioid Protocol (Intervention) | Total |
|---|---|---|---|
| United States | 64 | 63 | 127 |
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