Recruiting

Opioid Reduction

Sponsor:

Benaroya Research Institute

Code:

NCT04933084

Conditions

Prostatectomy

Opioid-Related Disorders

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pre-operative Opioid Education

Study Details

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.

Conditions

Prostatectomy

Opioid-Related Disorders

Study ID

NCT04933084

Start date

Sep 16, 2021

Status verified date

Dec, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Eyal Kord, MD

206-223-6772Eyal.Kord@virginiamason.org

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Eyal Kord, MD

206-223-6772Eyal.Kord@virginiamason.org

Debbie Sparks, CCRC

206-341-0896Deborah.Sparks@virginiamason.org

More Information

Sponsor

Benaroya Research Institute

Last update posted

Dec 21, 2023

Last verified

Dec, 2023

Keywords

  • Opioid Education
  • Post-operative Opioid Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2023-12-21.