Pre-operative Education Modalities to Decrease Opioid Use

Clinicaltrials.gov ID: NCT04933084
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 60

Conditions

Prostatectomy, Opioid-Related Disorders

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Una Lee, MD

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 Plan

Usual Care

NO_INTERVENTION

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

    Text Handout

    EXPERIMENTAL

    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

      Description:

      The pre-operative education in the text handout and pre-recorded video will include the topics of:nn1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.n2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.n3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.

    Text handout and Pre-recorded Video

    EXPERIMENTAL

    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

      Description:

      The pre-operative education in the text handout and pre-recorded video will include the topics of:nn1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.n2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.n3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.

    Outcome Measures

    Primary Outcome Measures

    In-hospital opioid use

    Time Frame: Immediately after the intervention/procedure/surgery

    Post-discharge opioid use

    Time Frame: Immediately after the intervention/procedure/surgery

    Post-operative pain

    Time Frame: Immediately after the intervention/procedure/surgery

    Return of bowel function

    Time Frame: Immediately after the intervention/procedure/surgery

    Secondary Outcome Measures

    Satisfaction with undergoing the surgery

    Time Frame: Immediately after the intervention/procedure/surgery

    Quality of life after undergoing surgery

    Time Frame: Immediately after the intervention/procedure/surgery

    Prolonged post-operative opioid use

    Time Frame: Up to 24 weeks

    Timeline

    • Last Updated
      December 21, 2023
    • Start Date
      June 21, 2021
    • Today
      May 12, 2025
    • Completion Date ( Estimated )
      May 1, 2024

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