Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Clinicaltrials.gov ID: NCT05597878
db-list-check Status RECRUITING
b-loader Phase PHASE2, PHASE3
b-people Age 40 - 75 Years
b-bullseye-arrow Enrollments 100

Conditions

Pain Management, Opioid Use, Prostate Cancer

Drugs

Oxycodone, Acetaminophen, Ketamine, Ketorolac, Acetaminophen

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Study Coordinator
  • 336-713-6627

Principal Investigator

  • Ashok Hemal, MD

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.

Study Plan

Opioid Control Cohort

ACTIVE_COMPARATOR

Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. AFTER surgery participants will be administered oxycodone and acetaminophen.

  • DRUG:

    Oxycodone

    Description:

    Given after surgery 5 mg every 6 hours as needed for severe pain.
  • DRUG:

    Acetaminophen

    Description:

    Given after surgery 1000 mg by mouth 4 times daily (every 6 hours)

Experimental Non-Opioid Cohort

ACTIVE_COMPARATOR

Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. BEFORE and AFTER surgery participants will be administered Ketamine; DURING surgery Ketorolac and acetaminophen.

  • DRUG:

    Ketamine

    Description:

    Given before and during surgery 1.5 mg/kg intravenously
  • DRUG:

    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).
  • DRUG:

    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)

Outcome Measures

Primary Outcome Measures

Change in Pain Scores

Time Frame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)

Secondary Outcome Measures

Opioid Oral Morphine Milligram Equivalents (OMEQ)

Time Frame: At Day 0 (Prior to surgery) and between Day 7-10 (postoperatively)

Demographics of Participants

Time Frame: Day 0 (prior to surgery) to Day 1 (expected hospital discharge)

Preoperative Characteristics of Participants

Time Frame: Day 0 (prior to surgery) to Day 1 (expected hospital discharge)

Opioid-Related Symptom Distress Scale (ORSDS)

Time Frame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)

Timeline

  • Last Updated
    April 18, 2024
  • Start Date
    October 28, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    February 1, 2025

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