Pre-operative Education Modalities to Decrease Opioid Use

December 20, 2023 updated by: Una Lee, Benaroya Research Institute

Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.
Experimental: Text Handout
This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.
Behavioral: Pre-operative Opioid Education

The pre-operative education in the text handout and pre-recorded video will include 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.
Experimental: Text handout and Pre-recorded Video
This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.
Behavioral: Pre-operative Opioid Education

The pre-operative education in the text handout and pre-recorded video will include 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital opioid use
Time Frame: Immediately after the intervention/procedure/surgery
Morphine equivalents used in the hospital will be calculated.
Immediately after the intervention/procedure/surgery
Post-discharge opioid use
Time Frame: Immediately after the intervention/procedure/surgery
Patient-reported number of opioid pills used after discharge (daily questionnaire).
Immediately after the intervention/procedure/surgery
Post-operative pain
Time Frame: Immediately after the intervention/procedure/surgery
Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain)
Immediately after the intervention/procedure/surgery
Return of bowel function
Time Frame: Immediately after the intervention/procedure/surgery
Patient-reported return of bowel function as time in days to first flatus and first bowel movement.
Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with undergoing the surgery
Time Frame: Immediately after the intervention/procedure/surgery
Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)
Immediately after the intervention/procedure/surgery
Quality of life after undergoing surgery
Time Frame: Immediately after the intervention/procedure/surgery
Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)
Immediately after the intervention/procedure/surgery
Prolonged post-operative opioid use
Time Frame: Up to 24 weeks
Incidence of prolonged postoperative opioid use defined by the American Society of Interventional Pain Physicians Guidelines as continued use beyond the normal and expected time of 90 days for surgical healing.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Investigators

  • Principal Investigator: Una Lee, MD, Virginia Mason Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRP20107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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