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SUSPENDED
NCT05597878
PHASE2/PHASE3

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-04-18

Completion Date

2026-05

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

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)

Locations (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States