Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

University of New Mexico (UNM)

Status: Completed

Conditions: Physical Activity; Abuses Over-The-Counter/Prescription Medications; Pain, Postoperative; Opioid Use; Patient Dependence on

Treatments: Behavioral: Patient centered pre-op education; Behavioral: routine preop education

Study type: Interventional

Funder types: Other

Identifiers

NCT03726476

18-262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Patient Centered pre-op education

Experimental group

Description:

Patient centered pre-operative education and patient centered post-operative care.

Treatment:

Behavioral: Patient centered pre-op education

Routine Pre-op education

Active Comparator group

Description:

Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics

Treatment:

Behavioral: routine preop education