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Pre-operative Education Modalities to Decrease Opioid Use

Sponsor
Benaroya Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933084
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
8
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pre-operative Opioid Education
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Triple-armed randomized control trialTriple-armed randomized control trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of Pre-operative Education Modalities to Decrease Opioid Use in Prostate Cancer Patients: A Prospective Randomized Control Trial
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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: 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.
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: 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.

Outcome Measures

Primary Outcome Measures

  1. In-hospital opioid use [Immediately after the intervention/procedure/surgery]

    Morphine equivalents used in the hospital will be calculated.

  2. Post-discharge opioid use [Immediately after the intervention/procedure/surgery]

    Patient-reported number of opioid pills used after discharge (daily questionnaire).

  3. Post-operative pain [Immediately after the intervention/procedure/surgery]

    Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain)

  4. Return of bowel function [Immediately after the intervention/procedure/surgery]

    Patient-reported return of bowel function as time in days to first flatus and first bowel movement.

Secondary Outcome Measures

  1. Satisfaction with undergoing the surgery [Immediately after the intervention/procedure/surgery]

    Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)

  2. Quality of life after undergoing surgery [Immediately after the intervention/procedure/surgery]

    Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)

  3. Prolonged post-operative opioid use [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Mason Medical Center Seattle Washington United States 98101

Sponsors and Collaborators

  • Benaroya Research Institute

Investigators

  • Principal Investigator: John Corman, MD, Virginia Mason Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
John Corman, MD, Staff Urologist, Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT04933084
Other Study ID Numbers:
  • CRP20107
First Posted:
Jun 21, 2021
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John Corman, MD, Staff Urologist, Benaroya Research Institute
Opioid Education
Post-operative Opioid Use
Additional relevant MeSH terms:
Opioid-Related Disorders
Analgesics, Opioid

Study Results

No Results Posted as of Jul 15, 2021