Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Stopped early · Phase 2/Phase 3

Conditions studied: Pain Management, Opioid Use, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05597878

Run by

Wake Forest University Health Sciences

People needed

58

Starts

2023-04-18

Expected to finish

2026-02-26

Last updated by the study team

2026-06-15

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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