Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Description

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.

Conditions

Pain Management, Opioid Use, Prostate Cancer

Study Overview

Study Details

Study overview

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.

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

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Condition
Pain Management
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Ashok Hemal, MD, PRINCIPAL_INVESTIGATOR, Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

2025-02