NSAID Use After Robotic Partial Nephrectomy

Phase 2RecruitingNCT05842044

University of Miami110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Kidney Cancer Renal Cancer Renal Neoplasm

Interventions

KetorolacDRUG

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

AcetaminophenDRUG

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

OxycodoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Up to 20 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Mark L Gonzalgo, MD, PhD

CONTACT

305-243-3246 m.gonzalgo@med.miami.edu

Data from ClinicalTrials.gov

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