NSAID Use After Robotic Partial Nephrectomy

Kidney Cancer Clinical Trial

— No-PAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842044
• Other study ID #: 20220783
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: Mark L Gonzalgo, MD, PhD
• Phone: 305-243-3246
• Email: m.gonzalgo[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms
• Renal Cancer
• Renal Neoplasm

Intervention

Drug:
• Ketorolac
15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
• Acetaminophen
1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
• Oxycodone
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.
• Hydromorphone
Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
• Ibuprofen
400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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