Skip to main content
Clinical Trials/NCT03726476
NCT03726476
Completed
Not Applicable

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

University of New Mexico2 sites in 1 country174 target enrollmentSeptember 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abuses Over-The-Counter/Prescription Medications
Sponsor
University of New Mexico
Enrollment
174
Locations
2
Primary Endpoint
Opioid Use at Approximately Two Weeks Post-op
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2019
End Date
December 6, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter C Jeppson

Principal Investigator, Assistant Professor

University of New Mexico

Eligibility Criteria

Inclusion Criteria

  • Subjects are ≥ 18 years of age
  • English or Spanish speaking
  • Patient scheduled for pelvic floor surgery

Exclusion Criteria

  • Unable to speak English or Spanish
  • Using long acting opioids (e.g. MS Contin, Fentanyl patch)
  • 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)

Outcomes

Primary Outcomes

Opioid Use at Approximately Two Weeks Post-op

Time Frame: 2 weeks

Morphine milligram equivalents at the two weeks post-op

Secondary Outcomes

  • Opioid Use at Approximately Six to Eight Weeks Post-op(6-8 weeks)

Study Sites (2)

Loading locations...

Similar Trials