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Pain ManagementPhase 2/3NCT05597878

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

A Phase 2/3 study testing Oxycodone, Acetaminophen and Ketamine in people with Pain Management and Opioid Use, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years, men only
Conditions the study is for
Pain Management, Opioid Use, Prostate Cancer
What is being tested?
Oxycodone, Acetaminophen and Ketamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
18 Apr 2023to 26 Feb 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the detailed description

Primary Objective(s): Compare the effectiveness of opioid and opioid-free pathways in treating post-surgical pain following robotic-assisted radical prostatectomy.

Secondary Objective(s)

  • To determine the opioid usage in the opioid and non-opioid group from the start of the pain treatment administration until discharge in patients following robotic-assisted radical prostatectomy.
  • Determine and analyze preoperative and perioperative measures for opioid and non-opioid groups in patients following robotic-assisted radical prostatectomy.
  • Examine and evaluate adverse effects of opioid and opioid-free pathways in patients following robotic-assisted radical prostatectomy using a standardized scale for common post-operative adverse effects including bodily functions.
Medical subject headings
Agnosia, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxycodoneDrug

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

  • AcetaminophenDrug

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

  • KetamineDrug

    Given before and during surgery 1.5 mg/kg intravenously

  • KetorolacDrug

    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).

  • AcetaminophenDrug

    Given during surgery 1 mg intravenously 4 times daily (every 6 hours). After surgery 1000 mg by mouth four times daily (every 6 hours)

Study groups in NCT05597878
Study groupRoleWhat they receive
Opioid Control CohortActive comparatorParticipants 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.
Receives: Drug: Oxycodone; Drug: Acetaminophen
Experimental Non-Opioid CohortActive comparatorParticipants 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.
Receives: Drug: Ketamine; Drug: Ketorolac; Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Opioid Oral Morphine Milligram Equivalents (OMEQ)

    OMEQ will be used to compare opioid use between groups. For continuous measures with skewed distributions, medians and interquartile range will be used as a summary. The comparisons between groups (opioid vs opioid free) will be done using t-tests, Kruskall-Wallis tests, or Chi-squared tests as appropriate.

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

  2. Demographics of Participants

    Demographics of participants such as age, race will also be used for comparative analysis between groups and will be will be summarized with means and standard deviations or counts and percentages as appropriate.

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

  3. Preoperative Characteristics of Participants

    Preoperative characteristics such as body mass index, prior abdominal surgeries, cancer risk category, American Society of Anesthesiology (ASA) score, and pre-operative prostate specific antigen (PSA) score will be summarized with means and standard deviations or counts and percentages as appropriate. Perioperative measures such as prostate cancer Grade Group, specimen weight, estimated blood loss, and length of stay (LOS) will also be used for comparative analysis between groups and will be summarized with means and standard deviations or counts and percentages as appropriate.

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

  4. Opioid-Related Symptom Distress Scale (ORSDS)

    A survey encompassing adverse effects using the Opioid-Related Symptom Distress Scale (ORSDS), will be administered to understand patient's experiences using the medication following robotic-assisted radical prostatectomy on a 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bother. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. The ORSDS score will be summarized using means and standard deviations by group.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start18 Apr 2023
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Why it stopped: Study initially suspended following an audit and need of amendment to address deficiencies. PI requested to terminate due to lack of support.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05597878
Sponsor's protocol ID
IRB00091354
Other IDs
P30CA012197, WFBCCC 01122
Status last verified
Jun 2026
First submitted
21 Oct 2022
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxycodone, Acetaminophen and Ketamine in people with Pain Management and Opioid Use, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study initially suspended following an audit and need of amendment to address deficiencies. PI requested to terminate due to lack of support.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Scores (time frame: Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05597878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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