Radical Prostatectomies
Conditions
Keywords
opioids, postoperative pain
Brief summary
This study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.
Detailed description
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).
Interventions
DRUGTramadol
Opioid Control Cohort (One treatment selected)
DRUGGabapentin
Experimental Cohort (Multimodal Approach)
Opioid Control Cohort (One treatment selected)
Opioid Control Cohort (One treatment selected)
DRUGKetorolac
Experimental Cohort (Multimodal Approach)
DRUGAcetaminophen
Experimental Cohort (Multimodal Approach)
DRUGKetorolac tromethamine
Experimental Cohort (Multimodal Approach)
DRUGKetamine
Experimental Cohort (Multimodal Approach)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Pain Score | 1 hour before surgery | 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 |
| Amount of medication used | 1 hour before surgery | measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured |
| Opioid-Related Symptom Distress Scale (ORSDS) | 1 hour before surgery | 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. |
Countries
United States
Outcome results
None listed