Clinical trial NCT03726476: Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Official title: Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abuses Over-The-Counter/Prescription Medications
Pain, Postoperative
Opioid Use
Physical Activity
Patient Dependence on
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Opioid Use at Approximately Two Weeks Post-op
timeFrame: 2 weeks
Secondary outcomes:
measure: Opioid Use at Approximately Six to Eight Weeks Post-op
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNMH Women's Care Clinic
state: New Mexico
city: Rio Rancho
country: United States
facility: UNM Sandoval Regional Medical Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Yuko Komesu, MD
role: STUDY_DIRECTOR
References: