cesarean section MedDRA version: 6.1 Level: PT Classification code 10006924
Conditions
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gathering of informed consent; ASA 1-2; Age between 18 and 40 years Maternal height between 150 and 190 cm, Maternal weight between 50 and 120 kg, Women who underwent elective or scheduled cesarean section. 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: Obstetrical complications associated with a higher hemorrhagic risk (e.g. central placenta praevia), Twin or multiple pregnancies, Inherited or acquired coagulation disorders, Skin infections or previous/actual spinal disorders, ASA >2, Urgent cesarean section, Severe clinical conditions that do not allow the enrollment of the patient, Use of experimental drugs within months before the inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To detect the most appropriate local anesthetic dose that results in effective subarachnoidal anesthesia in cesarean section , Ropivaina o Ropivacaine ?, for both surgical purpose and patient's ?comfort anesthesia;Primary end point(s): The ?stopping rule? will be reached when the confidence bound (95%) of the median dose of the drug will be small enough to exclude the value of the next dose in at least 5 consecutive triplets of patient;Secondary Objective: 1) Onset (time elapsed between subarachnoidal administration (T0) and achievement of L5 block) and duration of anesthesia 2) Intraoperative motor block 3) Hemodynamic impact of anesthetic block evaluated by measurement of blood pressure, heart rate (at various time intervals) and possible therapeutic adjustment (mg efedrina) needed to resolve hypotension and bradycardia 4) Duration of postoperative anesthetic block measured by the Bromage test ; 5) Duration of postoperative anesthesia as indicated by the time of first request for analgesic after operation | — |
Countries
Italy
Outcome results
None listed