This phase II/III trial compares the effect of an opioid free medication regimen, consisting of ketamine, ketorolac and acetaminophen, to an opioid containing medication regimen, consisting of oxycodone and acetaminophen, for pain control for patients undergoing robot assisted radical prostatectomy (RARP) for prostate cancer. Ketamine blocks pathways to the brain involved in sensing pain. Ketorolac is a non steroidal anti-inflammatory medication that may help relieve pain. Acetaminophen elevates the pain threshold and may help relieve pain. Oxycodone is an opioid, morphine-like medication that may help relieve pain. Receiving an opioid free medication regimen may result in less side effects than an opioid containing regimen while possibly still providing adequate pain control for patients undergoing RARP for prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05597878.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Ashok K. Hemal
Phone: 336-706-4131
PRIMARY OBJECTIVE:
I. Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robot assisted radical prostatectomy.
SECONDARY OBJECTIVES:
I. To determine the opioid usage in the opioid and non-opioid group from the start of the pain treatment administration until discharge in patients following RARP.
II. Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following RARP.
III. Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following RARP using a standardized scale for common post-operative adverse effects including bodily functions.
EXPLORATORY OBJECTIVE:
I. To evaluate total opioid usage in opioid and opioid-free pathways in patients following RARP from completion of prostatectomy until the patient’s post-operative follow-up appointment between day 7-day 10.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patient receives acetaminophen orally (PO) and oxycodone PO postoperative while on study.
ARM II: Patients receive ketamine intravenously (IV) and acetaminophen IV intraoperative, ketorolac IV intraoperative and postoperative and acetaminophen PO postoperative while on study. Patients may have opioid pain intervention escalation to oxycodone PO if pain becomes uncontrollable on study.
Trial PhasePhase II/III
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorAshok K. Hemal