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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| WFBCCC 01122 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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Study initially suspended following an audit and need of amendment to address deficiencies. PI requested to terminate due to lack of support.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Given after surgery 5 mg every 6 hours as needed for severe pain. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 0 (Prior to surgery) and between Day 7-10 (postoperatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Hemal, MD | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 26, 2025 | Jun 11, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| D007649 | Ketamine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Acetaminophen |
| Drug |
Given after surgery 1000 mg by mouth 4 times daily (every 6 hours) |
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| Ketamine | Drug | Given before and during surgery 1.5 mg/kg intravenously |
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| 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). |
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| Acetaminophen | Drug | Given during surgery 1 mg intravenously 4 times daily (every 6 hours). After surgery 1000 mg by mouth four times daily (every 6 hours) |
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| 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. | Day 0 (prior to surgery) to Day 1 (expected hospital discharge) |
| 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. | Day 0 (prior to surgery) to Day 1 (expected hospital discharge) |
| 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. | Day 0 (prior to surgery); Day 1 (expected hospital discharge) and between days 7-10 (day of postoperative follow up appointment) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |