Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04939987
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 59.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radical Prostatectomies	Drug: Tramadol; Drug: Gabapentin; Drug: Hydrocodone-Acetaminophen; Drug: Oxycodone-Acetaminophen; Drug: Ketorolac; Drug: Acetaminophen; Drug: Ketorolac tromethamine; Drug: Ketamine	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

2. Visual Analogue Pain Score [Baseline]

   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

3. Visual Analogue Pain Score [Day 1]

   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

4. Visual Analogue Pain Score [Day 3]

   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

5. 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

6. 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

7. Amount of medication used [Baseline]

   measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured

8. Amount of medication used [Day 1]

   measure opioid utilization by surveying patients on their usage while collecting their pain scores - Opioid oral morphine milligram equivalents (OMEQ) will be measured

9. 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

10. 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.

11. Opioid-Related Symptom Distress Scale (ORSDS) [Baseline]

    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.

12. Opioid-Related Symptom Distress Scale (ORSDS) [Day 1]

    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.

13. Opioid-Related Symptom Distress Scale (ORSDS) [Day 3]

    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.

14. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT04939987
• Other Study ID Numbers: IRB00074034
• First Posted: Jun 25, 2021
• Last Update Posted: Aug 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wake Forest University Health Sciences: opioids; postoperative pain
• Additional relevant MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine; Acetaminophen, hydrocodone drug combination; Ketamine; Oxycodone; Gabapentin; Tramadol; Hydrocodone; Analgesics, Opioid

Study Results

No Results Posted as of Aug 12, 2022