Opioid-sparing Effect of Intravenous Ibuprofen

Analgesia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03016650
• Other study ID #: muharrem-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 9, 2017
• Last updated: January 17, 2017
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: January 2017
• Source: Inonu University
• Contact: Muharrem Ucar, Asst.Prof.
• Phone: +90 422 341 06 60
• Email: umuharrem[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Percutaneous Nephrolithotomy

Intervention

Drug:
• Acetaminophen
Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
• Ibuprofen
Patients 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 PCNL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Muharrem Ucar

References & Publications (1)

Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Consumption		postoperatively 24 hours
Secondary	Visual Analog Scale		postoperatively 30 minute, 2, 4, 6,12 and 24 hours