Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Oct 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to manage pain after a robotic surgery for prostate cancer without relying on opioids, which are strong pain medications that can be addictive. Researchers want to compare two approaches: one group of patients will receive standard opioid treatment, while the other group will use a combination of other medications (ketamine, ketorolac, and acetaminophen) to control pain. If the opioid-free methods aren't enough for some patients, they may still be given opioids as needed.

To participate in this trial, men aged 40 to 75 who are scheduled for robotic-assisted surgery to treat prostate cancer may be eligible. Key requirements include having normal organ function and being able to understand and agree to participate in the study. Participants can expect to be monitored closely for their pain levels and overall recovery during and after the surgery. This trial is currently recruiting, and it aims to find safer pain management options for patients undergoing this type of surgery.

Gender

MALE

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.