Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

NCT05597878 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: IRB00091354WFBCCC 01122
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management; Opioid Use; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores

  Mean pain scores for opioid and opioid-free groups on Day 0, Day 1, and follow-up appointment between Day 7-10 will be summarized using means and standard deviations. To test that the Day 1 pain levels are not significantly worse in the opioid-free group than in the opioid group, a two sample one sided t-test with a null value of 1.5 for the difference between groups (the non-inferiority margin) will be used. The change in pain from day 0 to days 1, and 7-10 will be compared both within and between groups using t-tests. In addition, a repeated measures linear model, with pain as the outcome and selected demographics and group as covariates, will be used to assess the pain levels and changes in pain across time at all post-operative time points and between groups. Additional preoperative and perioperative covariates will be considered for the model.

  Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)

Secondary Outcomes (4)

• Opioid Oral Morphine Milligram Equivalents (OMEQ)

  At Day 0 (Prior to surgery) and between Day 7-10 (postoperatively)

• Demographics of Participants

  Day 0 (prior to surgery) to Day 1 (expected hospital discharge)

• Preoperative Characteristics of Participants

  Day 0 (prior to surgery) to Day 1 (expected hospital discharge)

• Opioid-Related Symptom Distress Scale (ORSDS)

  Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)

Study Arms (2)

Opioid Control Cohort

ACTIVE COMPARATOR

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.

Drug: Oxycodone; Drug: Acetaminophen

Experimental Non-Opioid Cohort

ACTIVE COMPARATOR

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.

Drug: Ketamine; Drug: Ketorolac; Drug: Acetaminophen

Interventions

Oxycodone DRUG

Given after surgery 5 mg every 6 hours as needed for severe pain.

Opioid Control Cohort

Ketamine DRUG

Given before and during surgery 1.5 mg/kg intravenously

Experimental Non-Opioid Cohort

Ketorolac DRUG

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).

Experimental Non-Opioid Cohort

Acetaminophen DRUG

Given after surgery 1000 mg by mouth 4 times daily (every 6 hours)

Opioid Control Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All men ages 40-75 undergoing robot assisted radical prostatectomy (RARP) with or without bilateral lymph node dissection with low, intermediate, or high-risk prostate cancer.
• Patients must have normal organ function as defined below:
• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
• Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

You may not qualify if:

• Participants with known allergies to any medication involved in the study or its excipients,
• Participants who are incarcerated persons,
• Participants with a chronic narcotic dependence,
• Participants with any prescription for narcotics in the past 30 days,
• Participants who have had only major pelvic or abdominal surgeries as bowel, rectal colon, bladder, liver, gallbladder, kidney, etc. in the past 6 months.
• Patients may not be receiving any other investigational agents.
• Patients with known metastatic disease or brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Agnosia; Prostatic Neoplasms

Interventions

Oxycodone; Acetaminophen; Ketamine; Ketorolac

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Ashok Hemal, MD

  Atrium Health Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 28, 2022
• Study Start: April 18, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)