Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedStudy Start
First participant enrolled
January 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2023
CompletedSeptember 1, 2023
August 1, 2023
4.3 years
January 15, 2019
August 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid use
Total opioid use
6 months after surgery
Secondary Outcomes (1)
Number of refills
6 months after surgery
Study Arms (2)
education
EXPERIMENTALThe 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).
no education
NO INTERVENTIONStandard preoperative care without dedicated teaching regarding opioid use and risks
Interventions
Eligibility Criteria
You may qualify if:
- years or older with capacity to consent
- presenting to UC Davis Medical Center Department of Orthopedic Surgery and planning to undergo elective shoulder surgery
You may not qualify if:
- unable to consent
- prisoners
- children
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Department of Orthopaedic Surgery
Sacramento, California, 95817, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Szabo, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2019
First Posted
January 17, 2019
Study Start
January 21, 2019
Primary Completion
May 4, 2023
Study Completion
May 4, 2023
Last Updated
September 1, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share