Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

Not Applicable

Completed

• Conditions: Abuses Over-The-Counter/Prescription Medications; Opioid Use; Physical Activity; Pain, Postoperative; Patient Dependence on
• Interventions: Behavioral: routine preop education; Behavioral: Patient centered pre-op education

• Registration Number: NCT03726476
• Lead Sponsor: University of New Mexico

Brief Summary

This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.

Detailed Description

Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education \& increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2019-09-10
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Results First Submitted: 2022-06-30
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

1. Subjects are ≥ 18 years of age
2. English or Spanish speaking
3. Patient scheduled for pelvic floor surgery

Exclusion Criteria

1. Unable to speak English or Spanish
2. Using long acting opioids (e.g. MS Contin, Fentanyl patch)
3. Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Pre-op education	routine preop education	Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics
Patient Centered pre-op education	Patient centered pre-op education	Patient centered pre-operative education and patient centered post-operative care.

Primary Outcome Measures

Name	Time	Method
Opioid Use at Approximately Two Weeks Post-op	2 weeks	Morphine milligram equivalents at the two weeks post-op

Secondary Outcome Measures

Name	Time	Method
Opioid Use at Approximately Six to Eight Weeks Post-op	6-8 weeks	Morphine milligram equivalents at the six to eight weeks post-op

Trial Locations

Locations (2)

UNM Sandoval Regional Medical Center; 🇺🇸 Rio Rancho, New Mexico, United States

UNMH Women's Care Clinic; 🇺🇸 Albuquerque, New Mexico, United States