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

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ClinicalTrials.gov Identifier: NCT03726476
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Peter C Jeppson, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Abuses Over-The-Counter/Prescription Medications Pain, Postoperative Opioid Use Physical Activity Patient Dependence on Behavioral: Patient centered pre-op education Behavioral: routine preop education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Patient Centered pre-op education
Patient centered pre-operative education and patient centered post-operative care.
Behavioral: Patient centered pre-op education
To implement a patient centered education intervention to evaluate post-op narcotic use.

Active Comparator: Routine Pre-op education
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics
Behavioral: routine preop education
To implement routine patient education intervention to evaluate post-op narcotic use.




Primary Outcome Measures :
  1. Opioid use at approximately two weeks post-op [ Time Frame: 2 weeks ]
    Morphine milligram equivalents at the two weeks post-op


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726476


Contacts
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Contact: Peter Jeppson, MD 505-967-8428 PJeppson@salud.unm.edu
Contact: Karen Taylor, BA 505-967-8428 HSC-Urogyn-Research@salud.unm.edu

Locations
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United States, New Mexico
UNMH Women's Care Clinic Recruiting
Albuquerque, New Mexico, United States, 87112
Contact: Karen Taylor, BA    505-967-8428    HSC-Urogyn-Research@salud.unm.edu   
Contact: Katherine Mulle, BA    505-967-8428    HSC-Urogyn-Research@salud.unm.edu   
UNM Sandoval Regional Medical Center Recruiting
Rio Rancho, New Mexico, United States, 87144
Contact: Karen Taylor, BA    505-967-8428    HSC-Urogyn-Research@salud.unm.edu   
Contact: Katherine Mulle, BA    505-967-8428    HSC-Urogyn-Research@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Investigators
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Study Director: Yuko Komesu, MD University of New Mexico

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Responsible Party: Peter C Jeppson, Principal Investigator, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03726476     History of Changes
Other Study ID Numbers: 18-262
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents