Clinical trial NCT04491617: STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
Official title: STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Prolapse; Female
Incontinence
Keywords: Opioids
Gynecology
Pain control
Prolapse
Incontinence
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit
timeFrame: 6-weeks
Secondary outcomes:
measure: Pain Level Scores During First Postoperative Week
timeFrame: 1-week
measure: Opioid Usage in the First Postoperative Week
timeFrame: 1-week
measure: Number of Participants Who Requested a New Opioid Prescription or Opioid Refill
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Cecile A Ferrando, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.