NSAID Use After Robotic Partial Nephrectomy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
Drug15-30mg Ketorolac administered via injection during intraoperative period every six (6) hours during post-surgery (inpatient) period.
Acetaminophen
Drug1000mg Acetaminophen administered orally during preoperative period. Standardized regimen of Acetaminophen administered during post-surgery (inpatient) period, during postoperative follow-up period.
Oxycodone
DrugStandardized 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
DrugStandardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Ibuprofen
Drug400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Group 1: NSAIDExperimental treatment 5 interventions
Group B: Group 2: No-NSAIDActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 hours2
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 days3
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 days4
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 daysSponsors and contacts
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Source ClinicalTrials.gov