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

NCT04491617 | Completed Results

• 1 other identifier: 20-682
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Opioid Use; Prolapse; Female; Incontinence

Keywords

Opioids; Gynecology; Pain control; Prolapse; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Pain Level Scores During First Postoperative Week

  1-week

• Opioid Usage in the First Postoperative Week

  1-week

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

  6-weeks

Study Arms (2)

Standard Opioid Protocol (Control)

ACTIVE COMPARATOR

Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery

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

Other: Restrictive opioid prescribing

Interventions

Standard opioid prescribing OTHER

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

Standard Opioid Protocol (Control)

Restrictive opioid prescribing OTHER

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

Restrictive Opioid Protocol (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (7)

• 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.

  PMID: 27631771 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.

  PMID: 29238810 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.

  PMID: 31154092 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.

  PMID: 30646274 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.

  PMID: 32199926 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.

  PMID: 22777367 BACKGROUND

• 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.

  PMID: 37863158 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Prolapse; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Cecile Ferrando, M.D.
• Organization: Cleveland Clinic

ferranc2@ccf.org

216-444-0642

Study Officials

• Cecile A Ferrando, M.D., M.P.H.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 29, 2020
• Study Start: August 27, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: January 24, 2025
• Results First Posted: September 25, 2024

Record last verified: 2025-01

Locations

US (1)