Subarachnoid Administration of Levobupivacaine for Cesarean Section
NCT ID: NCT01582607
Last Updated: 2012-04-20
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
130 participants
INTERVENTIONAL
2010-01-31
2012-05-31
Brief Summary
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Detailed Description
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Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group B
subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
Bupivacaine plain
2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
Group R
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
Ropivacaine plain
2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
Group LB
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
Levobupivacaine plain
2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
Group RF
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
ropivacaine plain +. fentanyl
2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
Group BF
subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
bupivacaine plain +fentanyl
2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
Group LBF
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Levobupivacaine plain +fentanyl
2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
Interventions
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Bupivacaine plain
2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
Ropivacaine plain
2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
Levobupivacaine plain
2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
bupivacaine plain +fentanyl
2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
ropivacaine plain +. fentanyl
2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
Levobupivacaine plain +fentanyl
2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stillborn
* Normal cardiotocogram
Exclusion Criteria
* Height \<150cm or \>185cm
* Age (\<18, \>40)
* ASA \> II
* Multiple gestation
* Pregnancy complications (eclampsia, GDP, placenta previa, \>2 previous c section)
* Contraindication to spinal anaesthesia
* Failure to educate the patient, language barrier
* Patient preferred GA
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Patras
OTHER
Responsible Party
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Nikolaos G. Flaris
Anesthesiologist,MD
Principal Investigators
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Nikolaos G Flaris, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Patras
Kriton S Filos, Professor
Role: STUDY_DIRECTOR
University Hospital of Patras
Locations
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University Hospital of Patras, Department of Anesthesiology
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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3089
Identifier Type: -
Identifier Source: org_study_id
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