NCT05525975

Opioid Consumption and Disposal After Shoulder Arthroplasty

Completed NA Results posted Last updated 15 January 2026

What this trial tests

NA trial testing Educational materials in Opioid Use in 140 participants. Completed in 26 April 2024.

Timeline

21 November 2022

Primary endpoint
26 April 2024

26 April 2024

Quick facts

Lead sponsor	Brendan M. Patterson
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	140
Start date	21 November 2022
Primary completion	26 April 2024
Estimated completion	26 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Educational materials

Conditions studied

• Opioid Use — all drugs for Opioid Use →

Sponsor

Brendan M. Patterson

Who can join

Adults 21 to 99, any sex, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Proportion of Participants With > 10 Pills Left Unused. Primary · 2 weeks or 6 weeks after surgery

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.

Group	Value	95% CI
Control/Standard of Care	49
Education Arm	47

Opioid Disposal Secondary · 2-weeks or 6-weeks post-operative.

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.

Group	Value	95% CI
Control/Standard of Care	19
Education Arm	22

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of interventions designed to increase safe medicine disposal: a systematic review and meta-analysis of randomised trials.
   Ma AS, McLachlan AJ, Abdel Shaheed C, Gnjidic D, et al · · 2025 · cited 1× · PMID 40450368 · DOI 10.1186/s13643-025-02820-4