Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Tramadol
- Conditions
- Radical Prostatectomies
- Sponsor
- Wake Forest University Health Sciences
- Locations
- 1
- Primary Endpoint
- Amount of medication used
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Opioid Control Cohort
One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Intervention: Tramadol
Opioid Control Cohort
One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Intervention: Hydrocodone-Acetaminophen
Opioid Control Cohort
One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Intervention: Oxycodone-Acetaminophen
Experimental Cohort
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Intervention: Gabapentin
Experimental Cohort
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Intervention: Ketorolac
Experimental Cohort
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Intervention: Acetaminophen
Experimental Cohort
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Intervention: Ketorolac tromethamine
Experimental Cohort
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Intervention: Ketamine
Outcomes
Primary Outcomes
Amount of medication used
Time Frame: Time of Discharge postoperative up to Day 3
measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured
Visual Analogue Pain Score
Time Frame: Day 7
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
Opioid-Related Symptom Distress Scale (ORSDS)
Time Frame: Day 7
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.