Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

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

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

Study Overview

• Status: Withdrawn
• Conditions: Radical Prostatectomies
• Intervention / Treatment: Drug: Tramadol; Drug: Hydrocodone-Acetaminophen; Drug: Oxycodone-Acetaminophen; Drug: Gabapentin; Drug: Ketorolac; Drug: Acetaminophen; Drug: Ketorolac tromethamine; Drug: Ketamine

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 Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ram Pathak, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: postoperative pain; opioids
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Respiratory System Agents; Antitussive Agents; Ketamine; Gabapentin; Ketorolac; Acetaminophen; Tramadol; Oxycodone; Analgesics, Opioid; Ketorolac Tromethamine; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: IRB00074034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No