Opioid-free pain management after robotic prostate surgery

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

This study tests if a pain management plan without opioids can help men aged 40-75 recover better after robotic prostate surgery compared to using traditional opioid treatments.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Male
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT05597878 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of an opioid-free pain control regimen compared to traditional opioid treatment for patients undergoing robotic-assisted radical prostatectomy. Participants will receive a combination of ketamine, ketorolac, and IV acetaminophen during and after surgery, with the option to escalate to opioids if necessary. The study aims to assess pain management outcomes, opioid usage, and potential adverse effects associated with both treatment pathways. It includes men aged 40-75 with varying risk levels of prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are men aged 40-75 undergoing robotic-assisted radical prostatectomy for prostate cancer.

Not a fit: Patients with chronic narcotic dependence or recent narcotic prescriptions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce opioid use and its associated risks in post-surgical pain management.

How similar studies have performed: Other studies have explored opioid-sparing strategies, showing promising results, but this specific approach is relatively novel.

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.

Where this trial is running

Winston-Salem, North Carolina

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

Study contacts

• Principal investigator: Ashok Hemal, MD — Atrium Health Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Study Coordinator

Conditions Pain Management; Opioid Use; Prostate Cancer