Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
NCT ID: NCT01558713
Last Updated: 2012-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2010-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group BFS
Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Bupivacaine- Fentanyl - Normal Saline
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Group RFS
Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Ropivacaine-Fentanyl-Normal Saline
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Group LFS
Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Levobupivacaine- Fentanyl- Normal Saline
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
BupivacaineF
Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
Bupivacaine + Fentanyl
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
RopivacaineF
Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
Ropivacaine + Fentanyl
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
LevobupivacaineF
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
Levobupivacaine + Fentanyl
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Interventions
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Bupivacaine- Fentanyl - Normal Saline
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Ropivacaine-Fentanyl-Normal Saline
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Levobupivacaine- 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 + Fentanyl
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Ropivacaine + Fentanyl
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
Levobupivacaine + Fentanyl
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-II
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Patras
OTHER
Responsible Party
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SKLAVOU CHRISTINA
Anesthesiologist- MD
Principal Investigators
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KRITON S FILOS, PROFESSOR
Role: STUDY_CHAIR
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Christina G Sklavou, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras
Locations
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Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Pátrai, Achaia, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1312010-25
Identifier Type: -
Identifier Source: org_study_id
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