Opioid-sparing Effect of Intravenous Ibuprofen

Phase 4

• Conditions: Analgesia; Percutaneous Nephrolithotomy
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT03016650
• Lead Sponsor: Muharrem Ucar

Brief Summary

The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).

Detailed Description

Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).

The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.

Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.

Exclusion Criteria

• chronic pain,
• psychiatric disease,
• renal dysfunction,
• allergy to nonsteroidal anti-inflammatory drugs,
• history of drug addiction,
• pregnancy,
• inability to use a patient controlled analgesia (PCA) device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	Acetaminophen	Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.
ibuprofen	Ibuprofen	Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively.

Primary Outcome Measures

Name	Time	Method
Morphine Consumption	postoperatively 24 hours

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	postoperatively 30 minute, 2, 4, 6,12 and 24 hours