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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group BFS | Active Comparator | Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
|
| Group RFS | Active Comparator | Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
|
| Group LFS | Active Comparator | Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9% |
|
| BupivacaineF | Active Comparator | Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY |
|
| RopivacaineF | Active Comparator | Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY. |
|
| LevobupivacaineF |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine- Fentanyl - Normal Saline | Drug | Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KRITON S FILOS, PROFESSOR | Contact | +302613603341 | +30 | kritonfilos@yahoo.gr |
| CHRISTINA G SKLAVOU, MD | Contact | +302613603346 | sklavou.christina@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| KRITON S FILOS, PROFESSOR | Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras | Study Chair |
| Christina G Sklavou, MD | Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras | Recruiting | Pátrai | Achaia | 26504 | Greece |
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| Active Comparator |
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY. |
|
| Ropivacaine-Fentanyl-Normal Saline | Drug | Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus |
|
|
| Levobupivacaine- Fentanyl- Normal Saline | Drug | Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus |
|
|
| Bupivacaine + Fentanyl | Drug | Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus |
|
|
| Ropivacaine + Fentanyl | Drug | Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus. |
|
|
| Levobupivacaine + Fentanyl | Drug | Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus |
|
|
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D000077212 | Ropivacaine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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