Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Acetaminophen; Ketamine; Ketorolac; Oxycodone

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 localized 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 with non-localized prostate cancer,

• 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 any surgery, other than prostate biopsy, 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.