An interventional study of Pre-operative Opioid Education in Prostatectomy and Opioid-Related Disorders, sponsored by Benaroya Research Institute. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Benaroya Research Institute · Not applicable, Interventional, and Prevention
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.
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:
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Benaroya Research Institute is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: 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.
Behavioral: 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.
In-hospital opioid use
Morphine equivalents used in the hospital will be calculated.
Time frame: Immediately after the intervention/procedure/surgery
Post-discharge opioid use
Patient-reported number of opioid pills used after discharge (daily questionnaire).
Time frame: Immediately after the intervention/procedure/surgery
Post-operative pain
Average pain over the course of today. (0=no pain, 5=moderate pain, 10=severe pain)
Time frame: Immediately after the intervention/procedure/surgery
Return of bowel function
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
Satisfaction with undergoing the surgery
Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied)
Time frame: Immediately after the intervention/procedure/surgery
Quality of life after undergoing surgery
Quality of life after the surgery. (1=worst possible QOL, 10=best possible QOL)
Time frame: Immediately after the intervention/procedure/surgery
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.
Time frame: Up to 24 weeks
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