Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Study Overview
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Brief Summary
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This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.

Detailed Description
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This study will conduct a randomized control double-blind clinical trial to evaluate an opioid versus a non-opioid pathway of gabapentin, ketorolac, and acetaminophen in treating postoperative pain following robot-assisted radical prostatectomy (RARP).

Official Title
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Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial

Conditions
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Radical Prostatectomies

Intervention / Treatment
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* Drug: Tramadol
* Drug: Gabapentin
* Drug: Hydrocodone-Acetaminophen
* Drug: Oxycodone-Acetaminophen
* Drug: Ketorolac
* Drug: Acetaminophen
* Drug: Ketorolac tromethamine
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (RARP) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer Exclusion Criteria: Allergies to any medication involved in the study T4 prostate cancer incarcerated persons chronic narcotic dependence any current prescription for narcotics any surgery in the past 6 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid Control Cohort<br>One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg) | Drug: Tramadol<br>* Opioid Control Cohort (One treatment selected)<br>* Other names: Opioid;Drug: Hydrocodone-Acetaminophen<br>* Opioid Control Cohort (One treatment selected)<br>* Other names: Opioid;Drug: Oxycodone-Acetaminophen<br>* Opioid Control Cohort (One treatment selected)<br>* Other names: Opioid;|
| Experimental: Experimental Cohort<br>Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4) | Drug: Gabapentin<br>* Experimental Cohort (Multimodal Approach)<br>Drug: Ketorolac<br>* Experimental Cohort (Multimodal Approach)<br>Drug: Acetaminophen<br>* Experimental Cohort (Multimodal Approach)<br>Drug: Ketorolac tromethamine<br>* Experimental Cohort (Multimodal Approach)<br>Drug: Ketamine<br>* Experimental Cohort (Multimodal Approach)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Score | Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable | 1 hour before surgery | 
| Visual Analogue Pain Score | Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable | Baseline | 
| Visual Analogue Pain Score | Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable | Day 1 | 
| Visual Analogue Pain Score | Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable | Day 3 | 
| Visual Analogue Pain Score | Pain scores will be collected using the Visual Analogue Pain Score and measured on a scale of 0-10, with 0 being no pain 10 being the worst pain imaginable | Day 7 | 
| Amount of medication used | measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured | 1 hour before surgery | 
| Amount of medication used | measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured | Baseline | 
| Amount of medication used | measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured | Day 1 | 
| Amount of medication used | measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured | Time of Discharge postoperative up to Day 3 | 
| Opioid-Related Symptom Distress Scale (ORSDS) | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. | 1 hour before surgery | 
| Opioid-Related Symptom Distress Scale (ORSDS) | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. | Baseline | 
| Opioid-Related Symptom Distress Scale (ORSDS) | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. | Day 1 | 
| Opioid-Related Symptom Distress Scale (ORSDS) | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. | Day 3 | 
| Opioid-Related Symptom Distress Scale (ORSDS) | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, postoperative pain