Patients with ASA classification I-III, female or male between 18 and 85 years of age, undergoing primary cementless unilateral total hip arthroplasty
Conditions
Interventions
Trade Name: Neodolpasse
Product Name: Neodolpasse
Product Code: not applicable
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: diclofenac sodium
Concentration unit: mg/l milligram(s)/li
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing primary cementless unilateral total hip arthroplasty under spinal anesthesia ASA classification I-III Female or male patients between 18 and 85 years of age Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known hypersensibility against the active ingredients diclofenac or orphenadrine Known hypersensibility against the other ingredients of the study medication History of stenosis or ulcera of the gastrointestinal tract within the last three (3) years prior to enrolment Renal insufficiency defined by a creatinine value equal or higher than 1.5 times the upper normal value Hepatic insufficiency defined by an ASAT or ALAT value equal or higher than 2.0 times the respective upper normal value Known severe asthma bronchiale defined by a reduction of vital capacity of the lung of 50% or more Haematopoiesis disorder Hemorrhagic diathesis Immuno-suppression Known glucose-6-phosphat dehydrogenase deficiency Porphyria Bone marrow suppression Inflammatory bowel disease or pancreatic disease Skeleton-motor system disease (e.g., myasthenia gravis) Severe hypertension defined as systolic blood pressure 25% or more above the normal value corrected for the patient’s age Patients with consequential damages or deficiencies due to stroke Patients with of uncontrolled cardiac arrhythmias, myocardial infarction, unstable myocardial ischemia, or any other serious cardiovascular diseases Participation in a clinical trial with an investigational drug or an investigational medical device within one month prior to start of study Repeated inclusion of the same patient in the course of a contra-lateral total hip arthroplasty or re-operation Patients with severe psychiatric diseases or epilepsy History or suspicion of drug abuse Abuse of alcoholic drinks, defined as an average daily intake of more than one litre of beer (i.e., 40 ml ethanol) per day or an equivalent amount of alcohol Pregnant or breast-feeding woman, or fertile woman not willing to use contraceptives during the study period Patient unable to co-operate adequately Patients with restricted legal capacity Persons, who are kept in custody in an institution according to legal or official directive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this clinical study is the evaluation of the efficacy of Neodolpasse™ Infusion Solution measured by a reduction of the demand for additional analgesic medication via PCA. Also the subjective pain relief will be tracked over the first 24 hours after the surgical intervention by using a Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) system. Furthermore the antipyretic efficacy and the local and systemic tolerability and safety of the Neodolpasse™ Infusion Solution will be assessed.;Secondary Objective: VAS and VRS pain score, incidence of pyrexia, local and systemic drug safety;Primary end point(s): The present study is intended to elucidate the analgesic efficacy of the Neodolpasse™ Infusion Solution by the reduction of the morphine demand in comparison to patients receiving placebo treatment and thus only morphine as analgesic drug. | — |
Countries
Austria
Outcome results
None listed