Dose-finding study of Ropivacain 5% with different doses of Sufentanil intrathecal at the combined spinal epidural anesthesia at labouring patients. If patients are requesting analgesia during labour, they receive combined spinal-epidural analgesia (CSE). Aim of the study is to find optimal dosage of Ropivacain and Sufentanil. The minimal local anesthetic dose (MLAD) of Ropivacain is evaluated by the method of Dixon and Massey.
Conditions
Interventions
Trade Name: Ropivacain 2mg/ml
Product Name: Naropin2mg/ml
Product Code: 1-25309
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sufentanil
CAS Number: 1–24352
Current Sponsor code: N
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female requesting analgesia during labour primi- or multipara ASA 1-2 36th to 41st gestational week cervix dilatation 2-6 cm VAS Score over 50mm 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: tranquilizers or opioids for premedication contraindication for spinal or epidural analgesia history of alcoolism or toxicomanie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: MLAD of Ropivacain intrathecal in combination with different dosages of Sufentanil.;Secondary Objective: Find optimal intrathecal concentration of drugs in order to have perfect analgesia with more or less no motor impairment in order to lower instrumental delivery rate.;Primary end point(s): - VAS score<10mm 15minutes after intrathecal injection, effect lasting at least 30 min. | — |
Countries
Austria
Outcome results
None listed