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Completed

NCT Number: NCT03726476

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient centered pre-op education

Behavioral

To implement a patient centered education intervention to evaluate post-op narcotic use.

routine preop education

Behavioral

To implement routine patient education intervention to evaluate post-op narcotic use.

Primary outcomes

  1. Opioid Use at Approximately Two Weeks Post-op

    Time frame: 2 weeks

    Morphine milligram equivalents at the two weeks post-op

Secondary outcomes

  1. Opioid Use at Approximately Six to Eight Weeks Post-op

    Time frame: 6-8 weeks

    Morphine milligram equivalents at the six to eight weeks post-op

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

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

Acronym: REPAIR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2018
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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