Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty

University of Regensburg (UR)

Status and phase

Completed

Phase 3

Conditions

Arthroplasties Hip Replacement

Perioperative Blood Loss

Coxarthrosis

Treatments

Drug: Etoricoxib

Drug: Diclofenac

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01229774

Eto-Dic-01

Details and patient eligibility

About

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?

Full 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.

Enrollment

100 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Indication for THA because of primary and secondary osteoarthritis of the hip.
male or female patients of the age of 55 - 85 years
informed consent afer having been informed in detail about the clinical trial by the investigator
negative pregnancy test (<= 2 days before inclusion) for women with child bearing potential (pre menopausal, <2 years menopausal, not surgically sterile), use of high security contraception methods as oral contraception agents or preservatives. The use of high security conception methods is also to obligatory for male patients

Exclusion criteria

Known hypersensitivity to one of the two investigational medical products or substaces of similar chemical structure or to any of the excipients
Patients who have experienced bronchospasm, asthma, acute rhinitis, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
unexplained dysfunction of haematopoiesis
treatment with NSAIDs or coxiben in the past 5 days before start of study
Active peptic ulceration or active gastro-intestinal (GI) bleeding
Pregnancy and lactation
Congestive heart failure (NYHA II-IV)
Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
clinically relevant disease of the cardiovascular system, severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10), severe renal dysfunction (estimated renal creatinine clearance <30 ml/min, clinical relevant disease of the nervous system, the endocrinium or another severe systematic disease
Systemic lupus erythematodes or mixed connective tissue disease
Inflammatory bowel disease
alcohol or drug abuse during the last past 3 months
Patients with hypertension BP persistently > 140/90mmHG) and has not been adequately controlled
life expectancy <6 months
state of mind which does not enable the patient to understand the nature of the study, its importance and possible consequences
evidence that the respective person will not cooperate with the study protocoll
participation of the patient in another clinical trial during the past 4 weeks before inclusion
prior participation in this clinical trial