major elective knee surgery (cruciate ligament surgery)
Conditions
Interventions
Trade Name: Neodolpasse-Infusionslösung
Product Name: Neodolpasse-Infusionslösung
Pharmaceutical Form: Infusion
INN or Proposed INN: diclofenac-sodium
Sponsors
Medical Univerity Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General enrolment criteria are: - Elective knee surgery (cruciate ligament surgery) - Confirmed patient suitability for planned surgery - Age 18 to = 85 years - Legally valid signed written informed consent provided - Female patients are confirmed non-pregnant or not breast feeding - Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients - No known intolerabilities / hypersensitivities to any part of the study medication - No reoperation/revision within 6 months after the initial surgery - Absence of history of abuse of analgesics or other drug - No analgesics within 48 hours prior to surgery (surgery-related excluded) - No current / recent (within 4 weeks prior to enrollment) experimental treatment - No current / recent (within 4 weeks prior to enrollment) participation in another clinical study - No foreseeable difficulties with regard to protocol compliance IMP-related enrollment criteria are: - Known hypersensibility against the active ingredients diclofenac or orphenadrine - Known hypersensibility against the other ingredients of the investigational medicinal product - Absence of congestive heart failure classes 2 or higher according to the NYHA classification - Absence of ischemic heart disease - Absence of peripheral arterial occlusive disease - Absence of cerebro-vascular disease - Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, type-2 diabetes, moderate smoking) 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 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Please refer to list of principal inclusion criteria (=enrolment criteria) for details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Trial objective is to investigate the use of additional analgesic medication via PCA during the first 24 hours postoperatively.;Secondary Objective: Assessment of the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion).;Primary end point(s): - Total dose of analgesic delivered by PCA over the first 48 hours post-surgery;Timepoint(s) of evaluation of this end point: - Total PCA dose: during first 48 hours post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pain intensity assessed during the first 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS) with focus on the infusion periods - Total dose of analgesic delivered by PCA over the first 8 and 16 hours post-surgery - Delirium state of the study patients assessed by Delirium Detection Score for Orphenadrine safety - Laboratory safety values, vital signs and adverse event profile until 48 hours post-surgery to assess overall safety and tolerability of IMP ; Timepoint(s) of evaluation of this end point: - Pain intensity (VAS): until 48 hours post-surgery (end of follow-up) - Total PCA dose: until 48 hours post-surgery (end of follow-up) - Delirium state: 4 hours after start of every IMP infusion - Laboratory safety values: at registration/randomization and until 48 hours post-surgery (end of follow-up) Vital signs: at registration/randomization Adverse event profile: until 48 hours post-surgery (end of follow-up) | — |
Countries
Austria
Contacts
Public ContactPrinciple Investigator
University Clinic for Anaesthesiology, Medical Univerity Vienna
Outcome results
None listed