NSAID Use After Robotic Partial Nephrectomy (No-PAIN)

University of Miami

Status and phase

Enrolling

Phase 2

Conditions

Renal Neoplasm

Renal Cancer

Kidney Cancer

Treatments

Drug: Oxycodone

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Ketorolac

Drug: Hydromorphone

Study type

Interventional

Funder types

Other

Identifiers

NCT05842044

20220783

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 2 patient groups

Group 1: NSAID

Experimental group

Description:

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.

Treatment:

Drug: Hydromorphone

Drug: Ketorolac

Drug: Ibuprofen

Drug: Acetaminophen

Drug: Oxycodone

Group 2: No-NSAID

Active Comparator group

Description:

Participants in this group will follow standard of care treatment. Participants will be in this group for approximately 21 days.

Treatment:

Drug: Hydromorphone