Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section

Conditions
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Stillborn Caesarean Section

Intervention / Treatment
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* Drug: Bupivacaine- Fentanyl - Normal Saline
* Drug: Ropivacaine-Fentanyl-Normal Saline
* Drug: Levobupivacaine- Fentanyl- Normal Saline
* Drug: Bupivacaine + Fentanyl
* Drug: Ropivacaine + Fentanyl
* Drug: Levobupivacaine + Fentanyl


Participation Criteria
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Eligibility Criteria
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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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group BFS<br>Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% | Drug: Bupivacaine- Fentanyl - Normal Saline<br>* Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus<br>* Other names: 0,9% Sodium Chloride Inj. BP, B.BRAUN Melsungen AG, German;|
| Active Comparator: Group RFS<br>Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% | Drug: Ropivacaine-Fentanyl-Normal Saline<br>* Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus<br>* Other names: 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG;|
| Active Comparator: Group LFS<br>Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% | Drug: Levobupivacaine- Fentanyl- Normal Saline<br>* Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus<br>* Other names: 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG;|
| Active Comparator: BupivacaineF<br>Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY | Drug: Bupivacaine + Fentanyl<br>* Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus<br>* Other names: Fentanyl, 50μg/ml (Janssen-Cilag, Belgium);|
| Active Comparator: RopivacaineF<br>Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY. | Drug: Ropivacaine + Fentanyl<br>* Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.<br>* Other names: Fentanyl 50μg/ml, Janssen-Cilag, Belgium.;|
| Active Comparator: LevobupivacaineF<br>Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY. | Drug: Levobupivacaine + Fentanyl<br>* Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus<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 |
| --- | --- | --- |
| Dermatomes of Sensory block | 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 | up to 120 minutes average | 
| Motor block | 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 | up to 120 minutes average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Pressure | 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 | up to 120 minutes average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parturient