Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Phase 2

Withdrawn

• Conditions: Radical Prostatectomies
• Interventions: Drug: Tramadol; Drug: Gabapentin; Drug: Hydrocodone-Acetaminophen; Drug: Ketorolac; Drug: Oxycodone-Acetaminophen; Drug: Acetaminophen; Drug: Ketorolac tromethamine; Drug: Ketamine

• Registration Number: NCT04939987
• Lead Sponsor: Wake Forest University Health Sciences

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).

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Status Verified: 2022-05
• Study Start: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-06
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Control Cohort	Hydrocodone-Acetaminophen	One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Opioid Control Cohort	Oxycodone-Acetaminophen	One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Experimental Cohort	Ketamine	Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Opioid Control Cohort	Tramadol	One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Experimental Cohort	Ketorolac	Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Experimental Cohort	Gabapentin	Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Experimental Cohort	Acetaminophen	Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Experimental Cohort	Ketorolac tromethamine	Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)

Primary Outcome Measures

Name	Time	Method
Amount of medication used	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	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)	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.

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States