Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Trial Title: Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

NCT ID: NCT05597878

Condition: Pain Management
Opioid Use
Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Acetaminophen
Ketorolac
Ketamine
Oxycodone

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Oxycodone
Description: Given after surgery 5 mg every 6 hours as needed for severe pain.
Arm group label: Opioid Control Cohort

Intervention type: Drug
Intervention name: Acetaminophen
Description: Given after surgery 1000 mg by mouth 4 times daily (every 6 hours)
Arm group label: Opioid Control Cohort

Intervention type: Drug
Intervention name: Ketamine
Description: Given before and during surgery 1.5 mg/kg intravenously
Arm group label: Experimental Non-Opioid Cohort

Intervention type: Drug
Intervention name: Ketorolac
Description: Given during surgery 15 mg or 30 mg intravenously 3 times daily (every 8 hours). After surgery 15 mg IV three times daily (every 8 hours).
Arm group label: Experimental Non-Opioid Cohort

Intervention type: Drug
Intervention name: Acetaminophen
Description: Given during surgery 1 mg intravenously 4 times daily (every 6 hours). After surgery 1000 mg by mouth four times daily (every 6 hours)
Arm group label: Experimental Non-Opioid Cohort

Summary: The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.

Detailed description: Primary Objective(s): Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robotic-assisted radical prostatectomy. Secondary Objective(s) - To determine the opioid usage in the opioid and non-opioid group from the start of the pain treatment administration until discharge in patients following robotic-assisted radical prostatectomy. - Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following robotic-assisted radical prostatectomy. - Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following robotic-assisted radical prostatectomy using a standardized scale for common post-operative adverse effects including bodily functions.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - All men ages 40-75 undergoing robot assisted radical prostatectomy (RARP) with or without bilateral lymph node dissection with low, intermediate, or high-risk prostate cancer. - Patients must have normal organ function as defined below: - AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal - Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. - Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: - Participants with known allergies to any medication involved in the study or its excipients, - Participants who are incarcerated persons, - Participants with a chronic narcotic dependence, - Participants with any prescription for narcotics in the past 30 days, - Participants who have had only major pelvic or abdominal surgeries as bowel, rectal colon, bladder, liver, gallbladder, kidney, etc. in the past 6 months. - Patients may not be receiving any other investigational agents. - Patients with known metastatic disease or brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Gender: Male

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Address:
City: Winston-Salem
Zip: 27157
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 336-713-6627

Investigator:
Last name: Ashok K Hemal, MD
Email: Principal Investigator

Start date: April 18, 2023

Completion date: February 2025

Lead sponsor:
Agency: Wake Forest University Health Sciences
Agency class: Other

Source: Wake Forest University Health Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05597878