Clinical trial NCT04933084: Pre-operative Education Modalities to Decrease Opioid Use
Official title: Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatectomy
Opioid-Related Disorders
Keywords: Opioid Education
Post-operative Opioid Use
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Triple-armed randomized control trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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:

1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. 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.

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

Primary outcomes:
measure: In-hospital opioid use
timeFrame: Immediately after the intervention/procedure/surgery
measure: Post-discharge opioid use
timeFrame: Immediately after the intervention/procedure/surgery
measure: Post-operative pain
timeFrame: Immediately after the intervention/procedure/surgery
measure: Return of bowel function
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Satisfaction with undergoing the surgery
timeFrame: Immediately after the intervention/procedure/surgery
measure: Quality of life after undergoing surgery
timeFrame: Immediately after the intervention/procedure/surgery
measure: Prolonged post-operative opioid use
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Una Lee, MD
role: PRINCIPAL_INVESTIGATOR
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