Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

NCT04939987 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB00074034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radical Prostatectomies

Keywords

opioids; postoperative pain

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

Opioid Control Cohort

ACTIVE COMPARATOR

One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)

Drug: Tramadol; Drug: Hydrocodone-Acetaminophen; Drug: Oxycodone-Acetaminophen

Experimental Cohort

EXPERIMENTAL

Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)

Drug: Gabapentin; Drug: Ketorolac; Drug: Acetaminophen; Drug: Ketorolac tromethamine; Drug: Ketamine

Interventions

Tramadol DRUG

Opioid Control Cohort (One treatment selected)

Also known as: Opioid

Opioid Control Cohort

Gabapentin DRUG

Experimental Cohort (Multimodal Approach)

Experimental Cohort

Hydrocodone-Acetaminophen DRUG

Opioid Control Cohort (One treatment selected)

Also known as: Opioid

Opioid Control Cohort

Oxycodone-Acetaminophen DRUG

Opioid Control Cohort (One treatment selected)

Also known as: Opioid

Opioid Control Cohort

Ketorolac DRUG

Experimental Cohort (Multimodal Approach)

Experimental Cohort

Acetaminophen DRUG

Experimental Cohort (Multimodal Approach)

Experimental Cohort

Ketorolac tromethamine DRUG

Experimental Cohort (Multimodal Approach)

Experimental Cohort

Ketamine DRUG

Experimental Cohort (Multimodal Approach)

Experimental Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Analgesics, Opioid; Gabapentin; oxycodone-acetaminophen; Ketorolac; Acetaminophen; Ketorolac Tromethamine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Ram Pathak, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 25, 2021
• Study Start: August 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)