Pre-operative Education Modalities to Decrease Opioid Use

Benaroya Research Institute

Status: Enrolling

Conditions: Prostatectomy; Opioid-Related Disorders

Treatments: Behavioral: Pre-operative Opioid Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04933084

CRP20107

Details and patient eligibility

About

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.

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:

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Usual Care

No Intervention group

Description:

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

Text Handout

Experimental group

Description:

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

Treatment:

Behavioral: Pre-operative Opioid Education

Text handout and Pre-recorded Video

Experimental group

Description:

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

Treatment:

Behavioral: Pre-operative Opioid Education