Prostate Cancer Clinical Trial

Pre-operative Education Modalities to Decrease Opioid Use

Summary

This is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. Patients will be randomized into three education arms: usual care (variable provider-dependent education), text handout, or text handout and pre-recorded video. The impact of patient education on outcomes of in-hospital, post-discharge, and persistent opioid use will be studied.

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Full Description

This is a triple-armed, randomized, controlled, non-blinded trial that will be conducted at Virginia Mason Medical Center (VMMC). Men of age 18 or older undergoing robotic assisted radical prostatectomy (RARP) for prostate cancer will be approached to participate in the study. Recruited patients will be randomized into three main groups based upon opioid education given to the patient before surgery: usual care group, text handout group, and text handout with pre-recorded video group.

During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. The study group will receive additional standardized pre-operative education including the topics of:

Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.

Patients in both usual care and study groups will receive standardized multimodal analgesia program with minimal opioids used.

Primary outcomes measured will include in-hospital and post-discharge opioid use, pain levels and time to return of bowel function. Secondary outcomes will include daily measures of patient satisfaction and quality of life, feeling of preparedness to manage post-operative pain, as well as incidence of prolonged opioid use at 90 days after surgery.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age > 18
Undergoing RARP at VMMC
Consent to participate in the study

Exclusion Criteria:

Long-term opioid use defined as use of opioids on most days for >3 months
History of drug or alcohol dependence
Concurrent surgery during radical prostatectomy
History of allergy to opioid analgesics, NSAIDs, acetaminophen or local anesthetics
Inability or unwillingness to give written informed consent

Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04933084

Recruitment Status:

Recruiting

Sponsor:

Benaroya Research Institute

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There is 1 Location for this study

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Virginia Mason Medical Center
Seattle Washington, 98101, United States More Info
Natasza Posielski, MD
Contact
253-951-8194
[email protected]
Debbie Sparks, CCRC
Contact
206-341-0896
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

60

Study ID:

NCT04933084

Recruitment Status:

Recruiting

Sponsor:


Benaroya Research Institute

How clear is this clinincal trial information?

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