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Pre-Operative Education for Managing Post-Surgical Pain

N/A

Recruiting

Led By Brendan M Patterson

Research Sponsored by Brendan M. Patterson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the surgical procedure

Awards & highlights

Study Summary

This trial is testing whether pre-operative education modules combined with a structured opioid disposal program will decrease opioid consumption following shoulder arthroplasty.

Who is the study for?

This trial is for patients at UIHC Shoulder Surgery Clinic scheduled for primary total shoulder replacement surgery. It's not for those with a history of chronic opioid use, contraindications to opioids, or needing revision or fracture-related arthroplasty.Check my eligibility

What is being tested?

The study tests if pre-op education on post-op opioid use and providing ways to dispose of unused opioids can reduce their consumption after shoulder replacement surgery. Participants will either receive this new approach or the standard care.See study design

What are the potential side effects?

Since the intervention involves educational materials and disposal mechanisms rather than medications, there are no direct side effects from drugs being tested in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the surgical procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid consumption with and without pre-operative opioid education

Secondary outcome measures

Opioid disposal

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Education ArmExperimental Treatment1 Intervention

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.

Group II: Control/Standard of CareActive Control1 Intervention

This arm will follow the standard of care practices of the Shoulder Surgery Department at UIHC, and will work as a control group.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brendan M. PattersonLead Sponsor

Brendan M PattersonPrincipal InvestigatorUniversity of Iowa

Media Library

Educational materials Clinical Trial Eligibility Overview. Trial Name: NCT05525975 — N/A

Opioid Use Disorder Research Study Groups: Education Arm, Control/Standard of Care

Opioid Use Disorder Clinical Trial 2023: Educational materials Highlights & Side Effects. Trial Name: NCT05525975 — N/A

Educational materials 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525975 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any stipulations for enrollment in this medical experiment?

"This medical trial is currently recruiting 136 individuals aged 21 to 99 who have had a history of opioid use. Furthermore, the inclusion criteria states that only patients seen at UIHC Shoulder Surgery Clinic and are indicated for primary total shoulder arthroplasty procedures will be accepted into this study."

Answered by AI

Are there still slots available to join this research endeavor?

"Currently, the clinical trial is open for enrollment as indicated on clinicaltrials.gov. This research was initially posted online on November 21st 2022 and has had recent updates to its information as of December 2nd 2022."

Answered by AI

How many participants have enrolled in this investigation thus far?

"Affirmative, the data hosted on clinicaltrials.gov shows that this experiment is actively searching for enrollees; with an initial posting date of November 21st 2021 and its most recent update occurring December 2nd 2021. This particular study requires 136 participants to join from a single site."

Answered by AI