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The purpose of this study is to see how effective non-steroidal anti-inflammatory drugs (NSAIDs) are at controlling pain without side effects in participants after robotic-assisted partial nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: NSAID | Experimental | Participants in this group will be prescribed NSAIDs instead of the standard of care treatment. Participants will be in this group for approximately 21 days. |
|
| Group 2: No-NSAID | Active Comparator | Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Opioid Use in Postoperative Period | Rate of opioid use is defined as the number of participants who used opioid medications during the post-operative period (defined as end of surgery to post-operative follow up visit) divided by total number of participants in the group at postoperative visit. | Up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Opioid Medication Use during Hospitalization | Rate of opioid medication use among study participants during hospitalization, defined as the number of participants who use opioid medication divided by total number of participants in the group during the time between surgery and discharge. | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark L Gonzalgo, MD, PhD | Contact | 305-243-3246 | m.gonzalgo@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark L Gonzalgo, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D004091 | Hydromorphone |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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After study recruitment, the patient will be randomized to the NSAID group (group 1) vs. the no-NSAID group (group 2). Randomization will be masked until after the renorrhaphy is completed and the surgical team will administer versus not administer ketorolac based on group assignment.
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| Acetaminophen | Drug | 1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period. |
|
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| Oxycodone | Drug | Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period. At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization. |
|
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| Hydromorphone | Drug | Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period. |
|
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| Ibuprofen | Drug | 400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days. |
|
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| Pain Score Assessed by Standardized Script |
At 24 hours post-surgery and during the postoperative follow-up period, pain score will be elicited from study participants using a standardized script, and scored on scale of 0 to 10, with 0 being no pain and 10 being the worst pain. |
| Up to 20 days |
| Pain Score Assessed by International Pain Outcome Questionnaire | Participants will complete the International Pain Outcome questionnaire during the postoperative and follow-up periods. Scores range from 0 to 10, with higher scores indicating more pain. | Up to 20 days |
| Number of Treatment-Related Adverse Events | The number of treatment-related of adverse events among study participants will be assessed by treating physician, post-surgery and after discharge during the postoperative period. | Up to 20 days |
| Change in Rate of Acute Kidney Injury | Rate of acute kidney injury at postoperative follow-up visit. Acute kidney injury is defined as a rise of Creatinine greater than (>) 0.3 from baseline. | Baseline, Up to 20 days |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |