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NCT Number: NCT05842044

NSAID Use After Robotic Partial Nephrectomy

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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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer Renal Neoplasm Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Mark L Gonzalgo, MD

CONTACT

[email protected]

305-243-3246

Mark L Gonzalgo, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Solitary kidney.
  • Pregnancy.
  • Inability to give informed consent or unable to meet requirement of the study for any reason.

Treatment and study plan

Ketorolac

Drug

15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.

Other names: Ketorolac tromethamine, Toradol, Biorolac

Acetaminophen

Drug

1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.

Other names: Tylenol

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.

Other names: Oxycontin, Roxicodone

Hydromorphone

Drug

Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.

Other names: Dihydromorphinone, Dilaudid, Hydromorph Contin, Palladone

Ibuprofen

Drug

400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.

Other names: Advil, Motrin

Primary outcomes

  1. 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.

Secondary outcomes

  1. Rate of Opioid Medication Use during Hospitalization

    Time frame: Up to 24 hours

    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.

  2. Pain Score Assessed by Standardized Script

    Time frame: Up to 20 days

    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.

  3. Pain Score Assessed by International Pain Outcome Questionnaire

    Time frame: Up to 20 days

    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.

  4. Number of Treatment-Related Adverse Events

    Time frame: Up to 20 days

    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.

  5. Change in Rate of Acute Kidney Injury

    Time frame: Baseline, Up to 20 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark L Gonzalgo, MD, PhD

CONTACT

[email protected]

305-243-3246

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial

Acronym: No-PAIN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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