NCT05597878

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

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

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective(s): Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robotic-assisted radical prostatectomy. Secondary Objective(s) * 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 robotic-assisted radical prostatectomy. * Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following robotic-assisted radical prostatectomy. * Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following robotic-assisted radical prostatectomy using a standardized scale for common post-operative adverse effects including bodily functions.

Conditions

• Pain Management
• Opioid Use
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Oxycodone	Given after surgery 5 mg every 6 hours as needed for severe pain.
DRUG	Acetaminophen	Given after surgery 1000 mg by mouth 4 times daily (every 6 hours)
DRUG	Ketamine	Given before and during surgery 1.5 mg/kg intravenously
DRUG	Ketorolac	Given during surgery 15 mg or 30 mg intravenously 3 times daily (every 8 hours). After surgery 15 mg IV three times daily (every 8 hours).
DRUG	Acetaminophen	Given during surgery 1 mg intravenously 4 times daily (every 6 hours). After surgery 1000 mg by mouth four times daily (every 6 hours)

Timeline

• Start date: 2023-04-18
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-10-28
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study