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Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm

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ClinicalTrials.gov Identifier: NCT03808025
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
The investigators aim to better understand opioid use in patients undergoing elective shoulder surgery. The investigators will prospectively determine actual postoperative opioid use, while evaluating whether implementation of an educational session with pain contract would help minimize opioid use.

Condition or disease Intervention/treatment Phase
Opioid Use Behavioral: opioid education Not Applicable

Detailed Description:
The investigators aim to better understand opioid use in patients undergoing elective shoulder surgery. As part of a multi-part investigation, The investigators intend to prospectively determine actual postoperative opioid use, while evaluating whether implementation of an educational session with pain contract would help minimize opioid use. Through use of a teaching session and pain contract, it is hypothesized opioid use would decrease. The investigators hypothesize the use of a pain contract and thorough discussion regarding proper opioid use and side-effects, will decrease the amount of postoperative opioid use.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Patients who consent to the study will be prospectively randomized to one of two arms: one will receive educational intervention, the other will not. Investigators will be masked to patient intervention when assessing and collecting outcomes.
Primary Purpose: Supportive Care
Official Title: Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: education
The teaching arm would consist of a standardized dialogue the surgeon will complete with the patient in order to familiarize the patient with the risks of over-prescribing opioid medication and set patient expectations regarding the clinic's opioid prescribing pattern protocol, in an effort to minimize the number of opioid pills prescribed or refills required, the amount actually used, and the untoward side effects of opioid use (e.g. respiratory depression, nausea, sedation, restriction from driving, and access to and use by those the medication was not intended).
 Behavioral: opioid education
see arm/group descriptions
No Intervention: no education
Standard preoperative care without dedicated teaching regarding opioid use and risks


Outcome Measures
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Primary Outcome Measures :
  1. Opioid use [ Time Frame: 6 months after surgery ]
    Total opioid use


Secondary Outcome Measures :
  1. Number of refills [ Time Frame: 6 months after surgery ]
    Necessary refills related to surgical pain


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older with capacity to consent
  • presenting to UC Davis Medical Center Department of Orthopedic Surgery and planning to undergo elective shoulder surgery

Exclusion Criteria:

  • unable to consent
  • prisoners
  • children
  • pregnant women
Contacts and Locations
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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): NCT03808025


Contacts
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Contact: Laura Sonoda, MD 9255704966 sonoda.laura@gmail.com
Contact: Matthew Zeiderman, MD 2092565888 mrzeiderman@ucdavis.edu

Locations
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United States, California
UC Davis Department of Orthopaedic Surgery Recruiting
Sacramento, California, United States, 95817
Contact: Laura Sonoda, MD    925-570-4966    sonoda.laura@gmail.com   
Principal Investigator: Robert Szabo, MD, MPH         
Sub-Investigator: Laura Sonoda, MD         
Sub-Investigator: Erika Valentine, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Robert M Szabo, MD University of California, Davis
More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03808025    
Other Study ID Numbers: 1333215
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents