Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

NCT03726476 | Completed Results

• 1 other identifier: 18-262
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Opioid Use at Approximately Two Weeks Post-op

  Morphine milligram equivalents at the two weeks post-op

  2 weeks

Secondary Outcomes (1)

• Opioid Use at Approximately Six to Eight Weeks Post-op

  6-8 weeks

Study Arms (2)

Patient Centered pre-op education

EXPERIMENTAL

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

Behavioral: Patient centered pre-op education

Routine Pre-op education

ACTIVE COMPARATOR

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

Behavioral: routine preop education

Interventions

Patient centered pre-op education BEHAVIORAL

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

Patient Centered pre-op education

routine preop education BEHAVIORAL

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

Routine Pre-op education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are ≥ 18 years of age
• English or Spanish speaking
• Patient scheduled for pelvic floor surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (2)

UNMH Women's Care Clinic

Albuquerque, New Mexico, 87112, United States

Location

UNM Sandoval Regional Medical Center

Rio Rancho, New Mexico, 87144, United States

Location

Related Publications (1)

• 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.

  PMID: 37428883 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Motor Activity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Results Point of Contact

• Title: Cassandra Darley
• Organization: University of New Mexico Health Sciences Center

cjdarley@salud.unm.edu

505-967-8428

Study Officials

• Yuko Komesu, MD

  University of New Mexico

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: October 31, 2018
• Study Start: September 10, 2019
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-02

Locations

US (2)