Subarachnoid Administration of Levobupivacaine for Cesarean Section

Study Overview
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Brief Summary
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The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.

Detailed Description
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Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date . 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.

Official Title
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Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.

Conditions
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Stillborn Caesarean Section

Intervention / Treatment
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* Drug: Bupivacaine plain
* Drug: Ropivacaine plain
* Drug: Levobupivacaine plain
* Drug: bupivacaine plain +fentanyl
* Drug: ropivacaine plain +. fentanyl
* Drug: Levobupivacaine plain +fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturients scheduled for elective c section Stillborn Normal cardiotocogram Exclusion Criteria: BMI>35kg/m2 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group B<br>subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% | Drug: Bupivacaine plain<br>* 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally<br>* Other names: Marcaine Spinal 5 mg/ml, AstraZeneca;|
| Active Comparator: Group R<br>subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% | Drug: Ropivacaine plain<br>* 2.0 ml (15mg) plain ropivacaine 0.75% intrathecally<br>* Other names: Naropeine 7.5mg/ml, AstraZeneca;|
| Active Comparator: Group LB<br>subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% | Drug: Levobupivacaine plain<br>* 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally<br>* Other names: Chirocaine 5mg/ml, Abbott Laboratories;|
| Active Comparator: Group RF<br>subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl | Drug: ropivacaine plain +. fentanyl<br>* 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally<br>* Other names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium;|
| Active Comparator: Group BF<br>subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl | Drug: bupivacaine plain +fentanyl<br>* 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally<br>* Other names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium;|
| Active Comparator: Group LBF<br>subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl | Drug: Levobupivacaine plain +fentanyl<br>* 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally<br>* Other names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block | sensory block (pin prick test): every 1 min until 30min, every 5 min until 60min. every 10 min until regression to O1 (average 150 minutes) | up to 150 minutes average | 
| Motor block | Motor block (Bromage scale): every 1 min until 30min, every 5 min until 60min. every 10 min until complete recovery of motor function (average 150 minutes) | up to 150 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics profile (arterial pressure. heart rate) | Measurement of arterial pressure and heart rate every 1 min for the first 30 min, every 5 min until 60 min, every 10 min until regression of sensory or motor block(average 150 minutes) | up to 150 minutes average |