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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opioid Use | Behavioral: opioid education | Not Applicable |
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 |
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).
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Behavioral: opioid education
see arm/group descriptions |
No Intervention: no education
Standard preoperative care without dedicated teaching regarding opioid use and risks
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- Opioid use [ Time Frame: 6 months after surgery ]Total opioid use
- Number of refills [ Time Frame: 6 months after surgery ]Necessary refills related to surgical pain

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

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
Contact: Laura Sonoda, MD | 9255704966 | sonoda.laura@gmail.com | |
Contact: Matthew Zeiderman, MD | 2092565888 | mrzeiderman@ucdavis.edu |
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 |
Principal Investigator: | Robert M Szabo, MD | University of California, Davis |
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 |
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 |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents |