Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm

Not Applicable

Completed

• Conditions: Opioid Use
• Interventions: Behavioral: opioid education

• Registration Number: NCT03808025
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Study Start: 2019-01-21
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
education	opioid 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).

Primary Outcome Measures

Name	Time	Method
Opioid use	6 months after surgery	Total opioid use

Secondary Outcome Measures

Name	Time	Method
Number of refills	6 months after surgery	Necessary refills related to surgical pain

Trial Locations

Locations (1)

UC Davis Department of Orthopaedic Surgery; 🇺🇸 Sacramento, California, United States