Dexketoprofen and Etoricoxib in Patients Undergoing Hip Arthroplasty (etoketo)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Etoricoxib; Drug: Dexketoprofen

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Etoricoxib; Etoricoxib 60mg if body weight≤ 60kg, 90mg if body weight 61-90kg and 120mg if body weight> 90kg by mouth	Drug: Etoricoxib; After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
ACTIVE_COMPARATOR: Dexketoprofen; Dexketoprofen 0,5 mg/kg up to 50 mg intravenously	Drug: Dexketoprofen; After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebrospinal fluid concentration dexketoprofen and etoricoxib	Cerebrospinal fluid concentration of dexketoprofen and etoricoxib	0-24 hours
Plasma concentration dexketoprofen and etoricoxib	Plasma concentration dexketoprofen and etoricoxib	0-24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain assessed with numeral rating scale	0-24 h

Collaborators and Investigators

• Sponsor: Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (ESTIMATE): October 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 30, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: pain; hip arthroplasty; Etoricoxib; Dexketoprofen
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib; Dexketoprofen trometamol
• Other Study ID Numbers: KUH30062008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO