Kidney CancerPhase 2No-PAINNCT05842044
NSAID Use After Robotic Partial Nephrectomy
A Phase 2 study testing Ketorolac, Acetaminophen and Oxycodone in people with Kidney Cancer and Renal Cancer, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Cancer, Renal Cancer, Renal Neoplasm
- What is being tested?
- Ketorolac, Acetaminophen and Oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
- Age 18-99.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Allergy to NSAIDs
- Myocardial infarction or unstable angina within 12 months.
- Any history of coronary artery bypass graft surgery.
- History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. Glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
- Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
- Chronic opioid use (use within 12 weeks) or history of opioid use disorder.
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- Solitary kidney.
- Pregnancy.
- Inability to give informed consent or unable to meet requirement of the study for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
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.
- Conditions
- Kidney Cancer, Renal Cancer, Renal Neoplasm
- Being tested
- Ketorolac, Acetaminophen, Oxycodone, Hydromorphone, Ibuprofen
- Keywords
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Ketorolac tromethamine, Toradol, Biorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
AcetaminophenDrug
Also called Tylenol
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
OxycodoneDrug
Also called Oxycontin, Roxicodone
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.
HydromorphoneDrug
Also called Dihydromorphinone, Dilaudid, Hydromorph Contin, Palladone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
IbuprofenDrug
Also called Advil, Motrin
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Hydromorphone; Drug: Ibuprofen |
| 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. Receives: Drug: Acetaminophen; Drug: Oxycodone; Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 days
Secondary outcomes (5)
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.
Measured: Up to 24 hours
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start15 Sep 2023
- Primary completion9 Oct 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark L. Gonzalgo, MD, PhD, University of Miami
- Investigators
- Mark L Gonzalgo, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842044
- Sponsor's protocol ID
- 20220783
- Acronym
- No-PAIN
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05842044
- Acronym / sponsor ID
- No-PAIN / 20220783
- Conditions
- Kidney Cancer, Renal Cancer, Renal Neoplasm
- Keywords
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: NSAID | Experimental | Drug: Ketorolac, Drug: Acetaminophen, Drug: Oxycodone, Drug: Hydromorphone, Drug: IbuprofenParticipants 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 | Drug: Acetaminophen, Drug: Oxycodone, Drug: HydromorphoneParticipants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing uncomplicated robotic assisted laparoscopic partial nephrectomy for renal mass at the University of Miami Hospital and Network Sites (Deerfield Beach, Plantation, Lennar (Coral Gables), and Kendal).
- Age 18-99.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (9 listed)
- Allergy to NSAIDs
- Myocardial infarction or unstable angina within 12 months.
- Any history of coronary artery bypass graft surgery.
- History or active peptic ulcer disease, gastrointestinal (GI) bleeding, GI perforation. History of bleeding disorder. Glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation).
- Taking any anti-platelet or anti-coagulation medications concurrently (e.g. warfarin, aspirin, clopidogrel, rivaroxaban etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: Ketorolac tromethamine, Toradol, Biorolac15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period. | Drug | Group 1: NSAID |
| AcetaminophenAlso: Tylenol1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period. | Drug | Group 1: NSAID, Group 2: No-NSAID |
| OxycodoneAlso: Oxycontin, RoxicodoneStandardized 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. | Drug | Group 1: NSAID, Group 2: No-NSAID |
| HydromorphoneAlso: Dihydromorphinone, Dilaudid, Hydromorph Contin, PalladoneStandardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period. | Drug | Group 1: NSAID, Group 2: No-NSAID |
| IbuprofenAlso: Advil, Motrin400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days. | Drug | Group 1: NSAID |
Primary outcome
Rate of Opioid Use in Postoperative Period
Time frame: Up to 20 days
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.
5 secondary outcomes
Rate of Opioid Medication Use during Hospitalization
Time frame: Up to 24 hours
Pain Score Assessed by Standardized Script
Time frame: Up to 20 days
Pain Score Assessed by International Pain Outcome Questionnaire
Time frame: Up to 20 days
Number of Treatment-Related Adverse Events
Time frame: Up to 20 days
Change in Rate of Acute Kidney Injury
Time frame: Baseline, Up to 20 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark L Gonzalgo, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac, Acetaminophen and Oxycodone in people with Kidney Cancer and Renal Cancer, run by University of Miami 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Opioid Use in Postoperative Period (time frame: Up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.