Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
- Conditions
- Stillborn Caesarean Section
- Interventions
- Drug: Bupivacaine- Fentanyl - Normal SalineDrug: Ropivacaine-Fentanyl-Normal SalineDrug: Levobupivacaine- Fentanyl- Normal Saline
- Registration Number
- NCT01558713
- Lead Sponsor
- University of Patras
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- Elective cesarean section
- ASA I-II
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RopivacaineF Ropivacaine + Fentanyl Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY. Group BFS Bupivacaine- Fentanyl - Normal Saline Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% Group RFS Ropivacaine-Fentanyl-Normal Saline Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% Group LFS Levobupivacaine- Fentanyl- Normal Saline Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% BupivacaineF Bupivacaine + Fentanyl Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY LevobupivacaineF Levobupivacaine + Fentanyl Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
🇬🇷Patras, Achaia, Greece