Opioid-Related Disorders, Prostatectomy
Conditions
Keywords
Opioid Education, Post-operative Opioid Use
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.
Interventions
BEHAVIORALPre-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.
Sponsors
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Triple-armed randomized control trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital opioid use | Immediately after the intervention/procedure/surgery | Morphine equivalents used in the hospital will be calculated. |
| Post-discharge opioid use | Immediately after the intervention/procedure/surgery | Patient-reported number of opioid pills used after discharge (daily questionnaire). |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Satisfaction with undergoing the surgery | Immediately after the intervention/procedure/surgery | Satisfaction with undergoing the surgery. (1=extremely dissatisfied, 10=extremely satisfied) |
Countries
United States
Contacts
Primary ContactEyal Kord, MD
Outcome results
None listed