Trial Outcomes & Findings for Opioid Consumption and Disposal After Shoulder Arthroplasty (NCT NCT05525975)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

140 participants

Primary outcome timeframe

2 weeks or 6 weeks after surgery

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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. 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.
Overall Study STARTED	68	72
Overall Study COMPLETED	63	64
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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. 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.
Overall Study Surgery cancellation	4	5
Overall Study didn't fill prescription	1	0
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control/Standard of Care n=63 Participants This arm will follow the standard of care practices of the Shoulder Surgery Department at UIHC, and will work as a control group.	Education Arm n=64 Participants 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. 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.	Total n=127 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 8.5 • n=63 Participants	68.1 years STANDARD_DEVIATION 7 • n=64 Participants	67.9 years STANDARD_DEVIATION 7.7 • n=127 Participants
Sex: Female, Male Female	23 Participants n=63 Participants	29 Participants n=64 Participants	52 Participants n=127 Participants
Sex: Female, Male Male	40 Participants n=63 Participants	35 Participants n=64 Participants	75 Participants n=127 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control/Standard of Care n=63 Participants This arm will follow the standard of care practices of the Shoulder Surgery Department at UIHC, and will work as a control group.	Education Arm n=64 Participants 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. 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.
Difference in Proportion of Participants With > 10 Pills Left Unused.	49 Participants	47 Participants

SECONDARY outcome

Timeframe: 2-weeks or 6-weeks post-operative.

Population: Percentage of participants who disposed unused opioid pills

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.

Outcome measures

Outcome measures
Measure	Control/Standard of Care n=60 Participants This arm will follow the standard of care practices of the Shoulder Surgery Department at UIHC, and will work as a control group.	Education Arm n=59 Participants 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. 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.
Opioid Disposal	19 Participants	22 Participants

Adverse Events

Control/Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brendan Patterson

University of Iowa Health Care

Phone: 319 678-8451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place