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TerminatedPhase 2 / Phase 3

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

NCT05597878 · Wake Forest University Health Sciences

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
58
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Pain Scores

    Measured over Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

40 Years to 75 Years
Ages
MALE
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth CarolinaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05597878 on ClinicalTrials.gov →

Last updated in the registry 2026-06-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits