Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm

August 30, 2023 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: 6 months after surgery
Total opioid use
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of refills
Time Frame: 6 months after surgery
Necessary refills related to surgical pain
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Robert M Szabo, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

May 4, 2023

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1333215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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