Pre-operative Education Modalities to Decrease Opioid Use
- Conditions
- Opioid-Related DisordersProstatectomy
- Interventions
- Behavioral: Pre-operative Opioid Education
- Registration Number
- NCT04933084
- Lead Sponsor
- Benaroya Research Institute
- 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:
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 60
- Age > 18
- Undergoing RARP at VMMC
- Consent to participate in the study
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Text Handout Pre-operative Opioid Education This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout. Text handout and Pre-recorded Video Pre-operative Opioid Education This group will receive limited opioid analgesia in conjunction with pre-operative education in the form of a text handout AND pre-recorded video.
- Primary Outcome Measures
Name Time Method In-hospital opioid use Immediately after the intervention/procedure/surgery Morphine equivalents used in the hospital will be calculated.
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)
Post-discharge opioid use Immediately after the intervention/procedure/surgery Patient-reported number of opioid pills used after discharge (daily questionnaire).
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
Name Time Method 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)
Satisfaction with undergoing the surgery Immediately after the intervention/procedure/surgery Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)
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.
Trial Locations
- Locations (1)
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States