Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty

Pain, Postoperative Clinical Trial

— etoketo  

Official title:

The Central Nervous Penetration of Dexketoprofen and Etoricoxib and Their Effect on Pain and Inflammatory Reaction in Patients Undergoing Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568735
• Other study ID #: KUH30062008
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: April 30, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. The secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin E2 and other proinflammatory markers both in plasma and cerebrospinal fluid. Thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• agreed to participate the study

• American Society of Anesthesiologist s physical status classification 1-3

• elective hip arthroplasty planned

• no contraindications to the study drugs

• no contraindication to lumbar puncture

Exclusion Criteria:

• refused to participate the study

• age less than 40 or over 75 years

• Planned anesthesia method other than spinal anesthesia

• contraindications to the study drugs

• Contraindications to lumbar puncture

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Dexketoprofen
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
• Etoricoxib
After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrospinal fluid concentration dexketoprofen and etoricoxib	Cerebrospinal fluid concentration of dexketoprofen and etoricoxib	0-24 hours
Primary	Plasma concentration dexketoprofen and etoricoxib	Plasma concentration dexketoprofen and etoricoxib	0-24 hours
Secondary	Pain	Pain assessed with numeral rating scale	0-24 h