Healthy pregnant women undergoing a planned c-section with an uncomplicated pregnancy of a singleton, "full-term", all between the age of 18-40 y (ASAI-II).
Conditions
Interventions
Trade Name: Marcaine hyperbaric
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BUPIVACAINE
CAS Number: 2180-92-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type:
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All healthy(ASA I-II) women with an uncomplicated singleton pregnancy between 18-40 y undergoing a planned caesarian. Pregnancy > or equal to 37 weeks. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Women who belong to ASA III-IV classification, BMI >35, length <150 cm, foetus with known fetal abnormality, pregnancy less than 37 weeks, known allergy for the used local anesthetics and (pre) eclampsia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this trial is to investigate the efficacy of the IMP during c-section with and without the use of Sufenta: As well as start of action, duration of action, the degree of motor and sensory block as well as the hight of the block itselfs will be investigated.;Secondary Objective: N/A;Primary end point(s): Earlier releave of motor block (less then 90' after injection).;Timepoint(s) of evaluation of this end point: End of c-section and final releave of motor block. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium
Contacts
Public ContactDepartment of Anesthesiology
UZ Brussel
Outcome results
None listed