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Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial (REPAIR)

Primary Purpose

Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient centered pre-op education
routine preop education
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abuses Over-The-Counter/Prescription Medications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • UNMH Women's Care Clinic
  • UNM Sandoval Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient Centered pre-op education

Routine Pre-op education

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid use at approximately two weeks post-op
Morphine milligram equivalents at the two weeks post-op

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2018
Last Updated
January 18, 2022
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03726476
Brief Title
Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Acronym
REPAIR
Official Title
Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use, Physical Activity, Patient Dependence on

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Centered pre-op education
Arm Type
Experimental
Arm Description
Patient centered pre-operative education and patient centered post-operative care.
Arm Title
Routine Pre-op education
Arm Type
Active Comparator
Arm Description
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics
Intervention Type
Behavioral
Intervention Name(s)
Patient centered pre-op education
Intervention Description
To implement a patient centered education intervention to evaluate post-op narcotic use.
Intervention Type
Behavioral
Intervention Name(s)
routine preop education
Intervention Description
To implement routine patient education intervention to evaluate post-op narcotic use.
Primary Outcome Measure Information:
Title
Opioid use at approximately two weeks post-op
Description
Morphine milligram equivalents at the two weeks post-op
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Opioid use at approximately six to eight weeks post-op
Description
Morphine milligram equivalents at the six to eight weeks post-op
Time Frame
6-8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuko Komesu, MD
Organizational Affiliation
University of New Mexico
Official's Role
Study Director
Facility Information:
Facility Name
UNMH Women's Care Clinic
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87112
Country
United States
Facility Name
UNM Sandoval Regional Medical Center
City
Rio Rancho
State/Province
New Mexico
ZIP/Postal Code
87144
Country
United States

12. IPD Sharing Statement

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Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

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