Opioid-sparing Effect of Intravenous Ibuprofen

Muharrem Ucar

Status and phase: Unknown; Phase 4

Conditions: Percutaneous Nephrolithotomy; Analgesia

Treatments: Drug: Acetaminophen; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03016650

muharrem-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Paracetamol

Active Comparator group

Description:

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.

Treatment:

Drug: Acetaminophen

ibuprofen

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen