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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05842044
Other study ID # 20220783
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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