Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

Pain, Postoperative Clinical Trial

— REPAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726476
• Other study ID #: 18-262
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: December 6, 2021

Study information

• Verified date: January 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Patient centered pre-op education
To implement a patient centered education intervention to evaluate post-op narcotic use.
• routine preop education
To implement routine patient education intervention to evaluate post-op narcotic use.

Locations

Country	Name	City	State
United States	UNMH Women's Care Clinic	Albuquerque	New Mexico
United States	UNM Sandoval Regional Medical Center	Rio Rancho	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use at approximately two weeks post-op	Morphine milligram equivalents at the two weeks post-op	2 weeks
Secondary	Opioid use at approximately six to eight weeks post-op	Morphine milligram equivalents at the six to eight weeks post-op	6-8 weeks