Opioid Consumption and Disposal After Shoulder Arthroplasty

NCT05525975 | Completed Results

• 1 other identifier: 202202119
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use

Keywords

opioid; Shoulder Arthroplasty; Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in Proportion of Participants With > 10 Pills Left Unused.

  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.

  2 weeks or 6 weeks after surgery

Secondary Outcomes (1)

• Opioid Disposal

  2-weeks or 6-weeks post-operative.

Study Arms (2)

Control/Standard of Care

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Educational materials OTHER

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.

Education Arm

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brendan M. Patterson: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (11)

• Bettlach CLR, Hasak JM, Santosa KB, Larson EL, Tung TH, Fox IK, Moore AM, Mackinnon SE. A Simple Brochure Improves Disposal of Unused Opioids: An Observational Cross-Sectional Study. Hand (N Y). 2022 Jan;17(1):170-176. doi: 10.1177/1558944720959898. Epub 2020 Oct 7.

  PMID: 33025827 BACKGROUND

• Lewis ET, Cucciare MA, Trafton JA. What do patients do with unused opioid medications? Clin J Pain. 2014 Aug;30(8):654-62. doi: 10.1097/01.ajp.0000435447.96642.f4.

  PMID: 24281287 BACKGROUND

• Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, YaDeau JT, Wu CL. Unused Opioid Pills After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 2017 Mar;45(3):636-641. doi: 10.1177/0363546517693665. Epub 2017 Feb 9.

  PMID: 28182507 BACKGROUND

• Saunders KW, Dunn KM, Merrill JO, Sullivan M, Weisner C, Braden JB, Psaty BM, Von Korff M. Relationship of opioid use and dosage levels to fractures in older chronic pain patients. J Gen Intern Med. 2010 Apr;25(4):310-5. doi: 10.1007/s11606-009-1218-z. Epub 2010 Jan 5.

  PMID: 20049546 BACKGROUND

• Sabesan VJ, Stankard M, Grauer J, Echeverry N, Chatha K. Predictors and prescribing patterns of opioid medications surrounding reverse shoulder arthroplasty. JSES Int. 2020 Oct 9;4(4):969-974. doi: 10.1016/j.jseint.2020.08.014. eCollection 2020 Dec.

  PMID: 33345242 BACKGROUND

• Martusiewicz A, Khan AZ, Chamberlain AM, Keener JD, Aleem AW. Outpatient narcotic consumption following total shoulder arthroplasty. JSES Int. 2020 Jan 16;4(1):100-104. doi: 10.1016/j.jses.2019.11.005. eCollection 2020 Mar.

  PMID: 32195470 BACKGROUND

• Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.

  PMID: 18686750 BACKGROUND

• Sabesan VJ, Chatha K, Koen S, Dawoud M, Gilot G. Innovative patient education and pain management protocols to achieve opioid-free shoulder arthroplasty. JSES Int. 2020 May 4;4(2):362-365. doi: 10.1016/j.jseint.2020.01.005. eCollection 2020 Jun.

  PMID: 32490427 BACKGROUND

• Hasak JM, Roth Bettlach CL, Santosa KB, Larson EL, Stroud J, Mackinnon SE. Empowering Post-Surgical Patients to Improve Opioid Disposal: A Before and After Quality Improvement Study. J Am Coll Surg. 2018 Mar;226(3):235-240.e3. doi: 10.1016/j.jamcollsurg.2017.11.023. Epub 2018 Jan 10.

  PMID: 29331347 BACKGROUND

• Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. J Bone Joint Surg Am. 2020 Jun 3;102(11):953-960. doi: 10.2106/JBJS.19.01166.

  PMID: 32251139 BACKGROUND

• Patel MS, Updegrove GF, Singh AM, Jamgochian GC, LoBiondo D, Abboud JA, Ramsey ML, Lazarus MD. Characterizing opioid consumption in the 30-day post-operative period following shoulder surgery: are we over prescribing? Phys Sportsmed. 2021 May;49(2):158-164. doi: 10.1080/00913847.2020.1789439. Epub 2020 Jul 9.

  PMID: 32597282 BACKGROUND

Results Point of Contact

• Title: Brendan Patterson
• Organization: University of Iowa Health Care

brendan-patterson@uiowa.edu

319 678-8451

Study Officials

• Brendan M Patterson

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: September 2, 2022
• Study Start: November 21, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: January 15, 2026
• Results First Posted: March 27, 2025

Record last verified: 2026-01

Locations

US (1)