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Completed

NCT Number: NCT02568735

Dexketoprofen and Etoricoxib 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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexketoprofen

Drug

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Etoricoxib

Drug

After total hip replacement surgery patient were given either etoricoxib or dexketoprofen

Primary outcomes

  1. Cerebrospinal fluid concentration dexketoprofen and etoricoxib

    Time frame: 0-24 hours

    Cerebrospinal fluid concentration of dexketoprofen and etoricoxib

  2. Plasma concentration dexketoprofen and etoricoxib

    Time frame: 0-24 hours

    Plasma concentration dexketoprofen and etoricoxib

Secondary outcomes

  1. Pain

    Time frame: 0-24 h

    Pain assessed with numeral rating scale

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Acronym: etoketo

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 6, 2015
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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