This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Opioid Control Cohort (One treatment selected)
Experimental Cohort (Multimodal Approach)
Opioid Control Cohort (One treatment selected)
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
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Opioid Control Cohort (One treatment selected)
Experimental Cohort (Multimodal Approach)
Experimental Cohort (Multimodal Approach)
Experimental Cohort (Multimodal Approach)
Experimental Cohort (Multimodal Approach)
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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7