Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial (REPAIR)

Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87112
      • UNMH Women's Care Clinic
    • Rio Rancho, New Mexico, United States, 87144
      • UNM Sandoval Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Centered pre-op education; Patient centered pre-operative education and patient centered post-operative care.	Behavioral: Patient centered pre-op education; To implement a patient centered education intervention to evaluate post-op narcotic use.
Active Comparator: Routine Pre-op education; Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics	Behavioral: routine preop education; To implement routine patient education intervention to evaluate post-op narcotic use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use at Approximately Two Weeks Post-op	Morphine milligram equivalents at the two weeks post-op	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use at Approximately Six to Eight Weeks Post-op	Morphine milligram equivalents at the six to eight weeks post-op	6-8 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Study Director: Yuko Komesu, MD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 6, 2021

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 18-262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No