women scheduled for elective breast surgery
Conditions
Interventions
Product Name: Dexamethason
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DEXAMETHASONE DINATRIUM PHOSPHATE
Other descriptive name: DEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EU
Sponsors
Medizinische Universität Innsbruck, Universitätsklinik für Anästhesie und Allgemeine Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: °female °ASA 1-2 °age 18-80 years °BMI 18-35 °informed consent °elective unilateral breast surgery 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: °bleeding disorders °known allergy to the administered drugs °diabetes °any disease that leads to an alteration in corticosteroid physiology °drug abuse (esp. Opioids) °systemic inflammation °psychiatric disorders that lead to an alteration in perception and evaluation of pain °tumor spread in the area of injection °Inflammation in the area of injection °pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to find out if dexamethason added to modified pectoral block (Pecs II) with ropivacain 0,2% prolongs analgetic effect;Secondary Objective: time to first opioid administration, VAS-score;Primary end point(s): total opioid consumption in the first 72h;Timepoint(s) of evaluation of this end point: after 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): time to first opioid administration, VAS-score (after 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours);Timepoint(s) of evaluation of this end point: time to first opioid administration, VAS-score (after 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours) | — |
Countries
Austria
Contacts
Public ContactKKS
Medizinische Universität Innsbruck
Outcome results
None listed