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Acetaminophen for Radical Prostatectomy

Phase 2 & 3
Waitlist Available
Led By Ashok K Hemal, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (RARP) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7
Awards & highlights

Study Summary

This study is evaluating whether a non-opioid pain medication can be used to reduce pain after prostatectomies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Fetal Distress
Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental CohortExperimental Treatment5 Interventions
Multimodal Approach: Gabapentin (100mg TID) Ketorolac (15mg q6) Acetaminophen (1mg IV q6) Ketamine (1.5mg/kg) Ketorolac tromethamine (15mg or 30mg Q4)
Group II: Opioid Control CohortActive Control3 Interventions
One treatment selected: Tramadol (50mg) Hydrocodone-Acetaminophen (2.5mg/325mg) Oxycodone-Acetaminophen (2.5mg/325mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Acetaminophen
2017
Completed Phase 4
~2030
Ketorolac tromethamine
2006
Completed Phase 3
~950
Ketorolac
2014
Completed Phase 4
~1760
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,237 Total Patients Enrolled
Ashok K Hemal, MDPrincipal InvestigatorWake Forest Health Sciences
1 Previous Clinical Trials
Ram Pathak, MDPrincipal InvestigatorWake Forest Health Sciences
1 Previous Clinical Trials
62 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy
2022. "Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04939987.
~0 spots leftby Apr 2025
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