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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (prior to surgery); day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment) for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Do I qualify?Apply below to find out