Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm

NCT ID: NCT03808025

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2023-05-04

Brief Summary

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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

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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.

Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

opioid education

Intervention Type BEHAVIORAL

see arm/group descriptions

no education

Standard preoperative care without dedicated teaching regarding opioid use and risks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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opioid education

see arm/group descriptions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert M Szabo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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UC Davis Department of Orthopaedic Surgery

Sacramento, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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1333215

Identifier Type: -

Identifier Source: org_study_id

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