Opioid Consumption and Disposal After Shoulder Arthroplasty

March 14, 2024 updated by: Brendan M. Patterson

The Impact of Pre-operative Opioid Education and Opioid Disposal Following Shoulder Arthroplasty

Opioid medications are widely used after many orthopedic procedures and are routinely prescribed after shoulder replacement surgery. Despite the high prevalence of opioid abuse and misuse, there is no standardized mechanism for patients to dispose of unused opioid medications safely and securely and the average number of opioid pills required after shoulder replacement surgery is still unknown. In a prior pilot study conducted by our group (IRB# 202012142), opioid consumption patterns of patients undergoing shoulder arthroplasty were analyzed, as well as their adherence to a safe and secure disposal mechanism for excess opioid pills. A 94% retention rate was achieved and preliminary results showed that most of the subjects were 60 years of age and older.

The objective of the current proposal is to: (1) develop pre-operative education materials related to post-operative opioid use following shoulder arthroplasty; (2) pilot the impact of this educational intervention; (3) examine the effect of providing disposal mechanisms for unused opioid pain medications following shoulder arthroplasty. The proposal is to conduct a single blinded randomized controlled trial of patients undergoing total shoulder replacement, both anatomic total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA), and Hemiarthroplasty at UIHC. This randomized controlled trial will compare: (1) education plus opioid disposal to the standard of care (SC). The investigators hypothesize that pre-operative opioid education modules combined with a structured opioid disposal program will decrease opioid consumption following shoulder arthroplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be identified as potential research subjects by one of the the two Shoulder Surgeons (BMP, JVN) during their visit to the Shoulder Surgery Clinic at University of Iowa Hospitals and Clinics, according to the indication of a shoulder arthroplasty.

During their preoperative work-up visit, patients will be invited to participate in the research study. The research coordinator will discuss the study with potential subjects in a private office or exam room. If the patient shows interest in participating, the research coordinator and the patient will go through the process of consent of participants.

After agreeing to participate and signing informed consent, participants will be randomized into one of the 2 study arms at their preoperative work-up visit.

Participants in Arm 1 (control group) will go through all procedures before and after their surgery as they usually do in standard of care practice, and all procedures will continue as scheduled. The standard of care practice of the Shoulder Surgery department at UIHC is that for patients that will undergo a surgical procedure NOT to receive any type of education on Opioid consumption, disposal or risks prior to the surgery.

Participants in Arm 2 (education + disposal), at their work-up visit, will receive a brochure, will watch an educational video, and will also receive an envelope in which they will be able to dispose their unused opioid pills. These envelopes will be the same ones used in the team's previous pilot study (IRB# 202012142). The disposal method consists of secured, labeled envelopes to dispose of the excess of Opioid medication. These envelopes will be provided by "Sharps Compliance, Inc.", a company that manages pharmaceutical waste disposal programs for healthcare facilities. Through their "TakeAway Medication Recovery System Envelope (USPS)" they allow the collection and disposal of controlled substances (Schedules II-IV) and non-controlled medications. Subjects will be explained how to use the envelope and that since it is labeled they will not have to pay for anything when using it. The brochure will address opioid risks, side effects, disposal and explain non-opioid pain management strategies. The educational video will consist of a short video to educate patients on the current opioid crisis, explain how to safely dispose of excess opioids and will teach them about drug-free pain management techniques.

All participants (Arm 1 and Arm2), after their surgery and after being discharged from the hospital, will receive daily text messages with a link to a REDCap survey. This texts will be delivered during the first 2 weeks following surgery. The survey will assess postoperative pain in the last 24 hours through Pain VAS, number of pills taken during the last 24 hours, number of pills disposed, method for disposal.

For participants who did not answer the daily survey and for the ones who are still taking opioids after 2 weeks following surgery, will be able to answer the survey at their postoperative appointment at Shoulder Surgery clinic (2-weeks postop or 6-weeks postop).

Patients in the education group will be emailed after their 6 week post-op visit to inquire as to their overall satisfaction with the education module and post-op buddy app/text program.

Disposal envelops will be tracked via tracking number just to confirm they were received by the disposal center (Sharps Compliance Inc.).

Study Type

Interventional

Enrollment (Estimated)

140

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 Contact

Study Contact Backup

Study Locations

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

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients seen at UIHC Shoulder Surgery Clinic that are indicated for primary total shoulder arthroplasty procedures.

Exclusion Criteria:

  • revision shoulder arthroplasty
  • arthroplasty for proximal humerus fractures
  • patients with a history of chronic opioid consumption
  • patients with contraindications for opioid consumption.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control/Standard of Care
This arm will follow the standard of care practices of the Shoulder Surgery Department at UIHC, and will work as a control group.
Experimental: Education Arm
Participants in this arm will receive at their preoperative work-up visit a brochure and will watch an educational video. Both educational materials (brochure and video) will address information about opioid medications, pain management techniques and properly disposal of any excess opioid medication. In addition, participants receive an envelope in which they will be able to dispose their unused opioid pills. These envelopes will be the same ones used in our pilot study (IRB# 202012142). The disposal method consists of secured, labeled envelopes to dispose of the excess of Opioid medication. These envelopes will be provided by "Sharps Compliance, Inc.", a company that manages pharmaceutical waste disposal programs for healthcare facilities. Through their "TakeAway Medication Recovery System Envelope (USPS)" they allow the collection and disposal of controlled substances (Schedules II-IV) and non-controlled medications.
Other: Educational materials
Educational materials will be developed by our interdisciplinary research team. Will consist of a brochure and a video. Both materials highlight important information about opioid medications, explain proper disposal of excess of opioid medications and provide drug-free pain management tools for postoperative pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption with and without pre-operative opioid education
Time Frame: Immediately after the surgical procedure

Educational materials will be developed and their impact will be tested on opioid consumption patterns after total shoulder arthroplasty.

By comparing Arm 1 and Arm 2 the investigators will determine the difference in opioid consumption between groups of patients who receive education and those who do not. Opioid consumption will be determined via patient self-reported opioid use on questionnaires completed during the first 2 weeks following surgery or at 6 weeks after surgery. The number of pills taken will be documented and will then be calculated by the research staff into MUE.
Immediately after the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid disposal
Time Frame: Immediately after the surgical procedure

Evaluate a structured and streamlined disposal protocol and its effect on opioid disposal rates.

By comparing Arm 1 and Arm 2 the investigators will determine opioid disposal between subjects provided a structured disposal mechanism and those who are not provided a structured disposal mechanism. Opioid disposal will be measured via patient self-report. In each group participants will be asked how many pills were left unused and how many pills were disposed. This will be recorded on the postoperative surveys administered during the first 2 weeks following surgery, or at 6 weeks after surgery.
Immediately after the surgical procedure

Collaborators and Investigators

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

Sponsor

Brendan M. Patterson

Investigators

  • Principal Investigator: Brendan M Patterson, University of Iowa

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.

General Publications

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)

November 21, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202202119

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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