Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

NCT ID: NCT03726476

Last Updated: 2024-07-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-12-06

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Patient Centered pre-op education

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

Group Type EXPERIMENTAL

Patient centered pre-op education

Intervention Type BEHAVIORAL

To implement a patient centered education intervention to evaluate post-op narcotic use.

Routine Pre-op education

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

Group Type ACTIVE_COMPARATOR

routine preop education

Intervention Type BEHAVIORAL

To implement routine patient education intervention to evaluate post-op narcotic use.

Interventions

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Patient centered pre-op education

To implement a patient centered education intervention to evaluate post-op narcotic use.

Intervention Type BEHAVIORAL

routine preop education

To implement routine patient education intervention to evaluate post-op narcotic use.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Peter C Jeppson

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuko Komesu, MD

Role: STUDY_DIRECTOR

University of New Mexico

Locations

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UNMH Women's Care Clinic

Albuquerque, New Mexico, United States

Site Status

UNM Sandoval Regional Medical Center

Rio Rancho, New Mexico, United States

Site Status

Countries

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United States

References

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Serna-Gallegos TR, Komesu YM, Dunivan GC, Meriwether KV, Ninivaggio CS, Petersen TR, Jeppson PC. Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study. Urogynecology (Phila). 2024 Jan 1;30(1):7-16. doi: 10.1097/SPV.0000000000001387. Epub 2023 Jun 27.

Reference Type DERIVED
PMID: 37428883 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-262

Identifier Type: -

Identifier Source: org_study_id

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