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Pre-operative Opioid Education for Opioid Use Disorder

N/A

Recruiting

Led By John Corman, MD

Research Sponsored by Benaroya Research Institute

Eligibility Criteria Checklist

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

Must have

Age > 18

Undergoing RARP at VMMC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the intervention/procedure/surgery

Awards & highlights

Study Summary

This trial studies how pre-op education affects opioid use after prostate surgery. Patients will get different types of education before surgery & outcomes of opioid use will be studied.

Who is the study for?

This trial is for adults over 18 who are scheduled to undergo a radical prostatectomy at VMMC and have consented to participate. It's designed to see if different types of pre-surgery education can reduce the need for opioids after surgery.Check my eligibility

What is being tested?

The study compares three ways of educating patients before surgery: usual care with varying information, a text handout, or both a text handout and video. The goal is to see which method best reduces opioid use after prostate surgery.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications, there are no direct side effects from drugs being tested. However, reduced opioid use could potentially affect pain management post-operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am scheduled for a robotic-assisted prostate surgery at VMMC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

In-hospital opioid use

Post-discharge opioid use

Post-operative pain

+1 more

Secondary outcome measures

Prolonged post-operative opioid use

Quality of life after undergoing surgery

Satisfaction with undergoing the surgery

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Text handout and Pre-recorded VideoExperimental Treatment1 Intervention

This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.

Group II: Text HandoutExperimental Treatment1 Intervention

This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.

Group III: Usual CareActive Control1 Intervention

During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Benaroya Research InstituteLead Sponsor

45 Previous Clinical Trials

11,257 Total Patients Enrolled

John Corman, MD4.323 ReviewsPrincipal Investigator - Virginia Mason Medical Center

Benaroya Research Institute

3 Previous Clinical Trials

127 Total Patients Enrolled

5Patient Review

We had an excellent experience with Dr. Corman at Virginia Mason. He was thorough in answering all our questions regarding robotic prostatectomy for an intermediate risk prostate cancer. The decision was difficult because of treatment options, but we are very pleased with the surgical result. Thank you Dr. Corman!

Una Lee, MDPrincipal InvestigatorVirginia Mason Medical Center

Frequently Asked Questions

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

What is the total number of participants in this clinical trial?

"Affirmative, the information hosted on clinicaltrials.gov states that this medical investigation is actively searching for candidates to participate in the study. It was initially posted on September 16th 2021 and last revised on April 12th 2023 with 60 participants being sought after from a single trial site."

Answered by AI

Is there any capacity for additional participants in this clinical experiment?

"Affirmative. Data available on clinicaltrials.gov indicates that this investigation, which was initially posted in September of 2021, is actively seeking patients. This trial requires the recruitment of 60 people across a single site to be completed."

Answered by AI

Recent research and studies

Journal of OrthopaedicsJournal

Effects of Preoperative Opioid Education on Postoperative Opioid Use and Pain Management in Orthopaedics: A Systematic Review

Rucinski, Kylee, and James L. Cook. 2020. “Effects of Preoperative Opioid Education on Postoperative Opioid Use and Pain Management in Orthopaedics: A Systematic Review”. Journal of Orthopaedics. Elsevier BV. doi:10.1016/j.jor.2020.01.020.

JAMA SurgeryJournal

New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults

Brummett, Chad M., Jennifer F. Waljee, Jenna Goesling, Stephanie Moser, Paul Lin, Michael J. Englesbe, Amy S. B. Bohnert, Sachin Kheterpal, and Brahmajee K. Nallamothu. 2017. “New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2017.0504.

The Journal of Hand SurgeryJournal

A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery

Alter, Todd H., and Asif M. Ilyas. 2017. “A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery”. The Journal of Hand Surgery. Elsevier BV. doi:10.1016/j.jhsa.2017.07.003.

Journal of Shoulder and Elbow SurgeryJournal