Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
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?
|Coxarthrosis Arthroplasties Hip Replacement Perioperative Blood Loss||Drug: Etoricoxib Drug: Diclofenac||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty, a Prospective, Double Blind, Phase III Study|
- Perioperative blood loss after implantation of a hip joint endoprosthesis [ Time Frame: Three days ]The primary objective of the study is the designation of the perioperative blood loss after implantation of a hip joint endoprosthesis under the influence of Etoricoxib or of Diclofenac. The expectations hypothesis is that under Etoricoxib patients will loose a smaller quantity of blood than under Diclofenac.
- Heterotopic ossification [ Time Frame: six months ]The secondary objectives are to investigate whether after hip joint endoprosthesis Etoricoxib can prevent heterotopic ossification in equal measure as Diclofenac
- Postoperative pain [ Time Frame: nine days ]It will be investigated if Diclofenac and Etoricoxib effectively reduce postoperative pain after hip joint endoprosthesis at rest and during movement.
- Reduction of rescue medication [ Time Frame: nine days ]It will be investigated whether Etioricoxib can reduce the use of rescue-medication as compared to Diclofenac
- Gastroinstestinal tolerance [ Time Frame: nine days ]It will be investigated if the gastrointestinal tolerance of Etoricoxib is superior to the one of Diclofenac
|Study Start Date:||February 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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
|Active Comparator: Diclofenac||
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229774
|Department of Orthopedic Surgery|
|Bad Abbach, Bavaria, Germany, 93077|