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Analgesic
Opioid-Free Pain Management for Prostate Cancer Surgery
Phase 2 & 3
Recruiting
Led By Ashok 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (prior to surgery); day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Awards & highlights
Summary
This trial will compare two pathways for pain relief during/after robotic-assisted prostatectomy: one with opioids, the other without. Opioid treatment can be escalated if needed.
Who is the study for?
Men aged 40-75 scheduled for robotic-assisted radical prostatectomy to treat localized prostate cancer can join. They must have normal liver and kidney function, no recent surgeries or narcotic prescriptions, and not be in prison. Participants with metastatic disease, unstable heart conditions, or chronic narcotic dependence are excluded.
What is being tested?
The trial is testing pain management strategies post-prostate surgery: one group receives ketamine, ketorolac, and acetaminophen without opioids; the other uses traditional opioid-based treatment (oxycodone). If necessary, patients on the opioid-free path may receive opioids.
What are the potential side effects?
Ketamine might cause changes in blood pressure, hallucinations or confusion. Ketorolac can lead to stomach issues or bleeding problems. Acetaminophen is generally safe but overuse can harm the liver. Oxycodone use carries a risk of addiction and common side effects like constipation and drowsiness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 (prior to surgery); day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (prior to surgery); day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Secondary study objectives
Demographics of Participants
Opioid Oral Morphine Milligram Equivalents (OMEQ)
Opioid-Related Symptom Distress Scale (ORSDS)
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Opioid Control CohortActive Control2 Interventions
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. AFTER surgery participants will be administered oxycodone and acetaminophen.
Group II: Experimental Non-Opioid CohortActive Control3 Interventions
Participants will receive standard general anesthesia and receive local anesthesia medication (bupivacaine) during surgery per the investigator's surgical protocol. BEFORE and AFTER surgery participants will be administered Ketamine; DURING surgery Ketorolac and acetaminophen.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,607 Total Patients Enrolled
20 Trials studying Prostate Cancer
1,669 Patients Enrolled for Prostate Cancer
Ashok Hemal, MDPrincipal InvestigatorAtrium Health Wake Forest Baptist Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been prescribed narcotics in the last 30 days.I have not had major surgery in my pelvis or abdomen in the last 6 months.I do not have cancer that has spread to my brain.I am a man aged 40-75 with prostate cancer, planning to undergo surgery.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My liver and kidney functions are within normal ranges.I can understand and am willing to sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid Control Cohort
- Group 2: Experimental Non-Opioid Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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