Labour
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sufentanil
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Solution for in
Sponsors
AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Well established labour  Maternal request of analgesia  Cervical dilatation ≤ 5 cm in nulliparous or ≤ 3 cm in multiparous patients  Vertex presentation  Written informed consensus 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:  ASA > II  Twin pregnancy  Congenital or acquired coagulation diseases (plts ≤ 70000/mmc, INR > 1,2, clinical evidence)  Use of anticoagulant or antiplatelet agents  Infection over the injection site  Marked hypovolemia  Nonreassuring fetal heart rate abnormalities  Unintentional dural puncture  Failing finding epidural space
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: : to compare the effects of epidural analgesia and combined spinal/epidural analgesia on uteroplacental circulation, maternal hemadynamics and the length of the first and second stage of labour;Secondary Objective: to evaluate the synergic role of opioid (sufentanil) and local anaesthetic (l-bupivacaine) and thus the minimal effective epidural local anaesthetic volume;Primary end point(s): less use of oxytocin and cut down of the length of the first stage of labour using combined spinal-epidural analgesia | — |
Countries
Italy
Outcome results
None listed