N/A
N=140
Opioid Consumption and Disposal After Shoulder Arthroplasty
Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT05525975 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Difference in Proportion of Participants With > 10 Pills Left Unused. — 49; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational materials (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Brendan M. Patterson
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Proportion of Participants With > 10 Pills Left Unused. |
49; 47 | — |
| SECONDARY Opioid Disposal |
19; 22 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05525975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.