Stillborn Caesarean Section
Conditions
Keywords
parturient
Brief summary
Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.
Detailed description
Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.
Interventions
DRUGBupivacaine- Fentanyl - Normal Saline
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
DRUGRopivacaine-Fentanyl-Normal Saline
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
DRUGLevobupivacaine- Fentanyl- Normal Saline
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
DRUGLevobupivacaine + Fentanyl
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Sponsors
University of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective cesarean section * ASA I-II
Exclusion criteria
* complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus) * abnormal fetal heart rate at the time of admission * body mass index \> 35 kg/m2 * height \<150cm and \>185 cm * age \<18 yrs and \>40 yrs * patients with contraindication to spinal anaesthesia( i.e anticoagulants) * ASA \>III * intraoperative excessive bleeding * patients with previous psychiatric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatomes of Sensory block | up to 120 minutes average | Dermatomes of sensory block(pin prick test) are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal of sensory block |
| Motor block | up to 120 minutes average | Motor block according to the Bromage scale are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal motor block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Blood Pressure | up to 120 minutes average | Measurements assesed every minute within the first 30 minutes after the intrathecal administration of local anesthetics and every 5 minutes until withdrawal of sensory and motor block |
Countries
Greece
Contacts
Primary ContactKRITON S FILOS, PROFESSOR
Backup ContactCHRISTINA G SKLAVOU, MD
Outcome results
None listed