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Pre-operative Education Modalities to Decrease Opioid Use

Primary Purpose

Prostatectomy, Opioid-Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-operative Opioid Education
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatectomy focused on measuring Opioid Education, Post-operative Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Care

Text Handout

Text handout and Pre-recorded Video

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction with undergoing the surgery
Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)
Quality of life after undergoing surgery
Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)
Prolonged post-operative opioid use
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.

Full Information

First Posted
June 11, 2021
Last Updated
April 12, 2023
Sponsor
Benaroya Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04933084
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatectomy, Opioid-Related Disorders
Keywords
Opioid Education, Post-operative Opioid Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Triple-armed randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider.
Arm Title
Text Handout
Arm Type
Experimental
Arm Description
This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout.
Arm Title
Text handout and Pre-recorded Video
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative Opioid Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
In-hospital opioid use
Description
Morphine equivalents used in the hospital will be calculated.
Time Frame
Immediately after the intervention/procedure/surgery
Title
Post-discharge opioid use
Description
Patient-reported number of opioid pills used after discharge (daily questionnaire).
Time Frame
Immediately after the intervention/procedure/surgery
Title
Post-operative pain
Description
Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain)
Time Frame
Immediately after the intervention/procedure/surgery
Title
Return of bowel function
Description
Patient-reported return of bowel function as time in days to first flatus and first bowel movement.
Time Frame
Immediately after the intervention/procedure/surgery
Secondary Outcome Measure Information:
Title
Satisfaction with undergoing the surgery
Description
Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)
Time Frame
Immediately after the intervention/procedure/surgery
Title
Quality of life after undergoing surgery
Description
Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)
Time Frame
Immediately after the intervention/procedure/surgery
Title
Prolonged post-operative opioid use
Description
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.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eyal Kord, MD
Phone
206-223-6772
Email
Eyal.Kord@virginiamason.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Una Lee, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eyal Kord, MD
Phone
206-223-6772
Email
Eyal.Kord@virginiamason.org
First Name & Middle Initial & Last Name & Degree
Debbie Sparks, CCRC
Phone
206-341-0896
Email
Deborah.Sparks@virginiamason.org

12. IPD Sharing Statement

Citations:
Citation
Overview | Drug Overdose | CDC Injury Center. Published March 19, 2020. Accessed November 5, 2020. https://www.cdc.gov/drugoverdose/data/prescribing/overview.html
Results Reference
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Pre-operative Education Modalities to Decrease Opioid Use

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