Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
Condition: Coxarthrosis; Arthroplasties Hip Replacement; Perioperative Blood Loss
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of this study is to test if etoricoxib decreases the perioperative blood loss
      compared to diclofenac.

      Secondary questions to be explored are:

        -  Does etoricoxib prevent Heterotopic ossification after Total Hip Arthroplasty as well as
           diclofenac ?

        -  Do diclofenac and etoricoxib both reduce pain at rest and on movements?

        -  Does etoricoxib compared to diclofenac reduce the amount of rescue medication
           (Oxycodon)?

        -  Does etoricoxib improve gastrointestinal tolerability compared to diclofenac?
    

Detailed description: 
      Total Hip Arthroplasty (THA) is a common surgical procedure in orthopaedic surgery which can
      be associated with perioperative blood loss and severe postoperative pain. Adequate pain
      management is very important to achieve early mobilisation in order to avoid
      immobility-induced complications. Non steroidal antirheumatic agents (NSAIDs) as selective
      Cox-2 inhibitors are commonly used in the management of postoperative pain. There exist
      non-selective and selective Cox-inihibitors. Non-selective NSAIDs block the systhesis of
      prostagandins by the two iso-enzymes of the cyclooxygenase, Cox-1 and Cox-2. For this reason
      the bleeding risk after operations (e.g.tonsillectomy) is increased.

      In this regard, the perioperative use of Cox-2 selective NSAIDs is advantageous for pain
      management after tonsillectomy. This could be shown for Rifecoxib, a selective Cox-2
      inihibitor. For THAs with treatment of Etoricoxib, also a selective Cox-2 inhibitor, possible
      complications as the increased risk of haematoma, gastrointestinal bleeding and the need of
      blood transfusion could possibly be reduced. Selective Cox-2 inhibitors do not interfere with
      the coagulation system. Study results show that other selective Cox-2 inhibitors like
      meloxicam reduce perioperative blood loss. Thus, besides ensuring a good perioperative pain
      management, selective Cox-2 inhibitors may in addition cause less blood loss than
      non-selective NSAIDs.This possible reduction of blood loss during pain management with
      Etoricoxib (Arcoxia) will be investigated the described clinical trial.

      Heterotopic ossification (HO) is a complication occurring after THA which can lead to
      postoperative pain and reduced function. Non-selective NSAIDs are commonly used in the
      prophylaxis of heterotopic ossifications after THA. The exact mechanism of prevention of bone
      formation is unclear. Some results indicate that the development of HO follows a Cox-2
      pathway. A further aim of this clinical trial is to investigate the efficacy of Etoricoxib in
      the prevention of heterotropic ossification.
    

Intervention name(s): Etoricoxib; Diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Arcoxia 90 mg once a day in the evening day -1 and 0 and once a day in the morning days 1-7 plus on tablett of placebo every evening; Voltaren Resinat 75mg once a day on day -1 and 0 in the evening; twice a day (in the morning and in the evening) days 1-7
Intervention MeSH terms: Diclofenac; Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment