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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Active Comparator | subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% |
|
| Group R | Active Comparator | subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% |
|
| Group LB | Active Comparator | subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% |
|
| Group RF | Active Comparator | subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl |
|
| Group BF | Active Comparator | subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl |
|
| Group LBF | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine plain | Drug | 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kriton S Filos, Professor | Contact | 2610999341 | 0030 | kritonfilos@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos G Flaris, MD | University Hospital of Patras | Principal Investigator |
| Kriton S Filos, Professor | University Hospital of Patras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras, Department of Anesthesiology | Recruiting | Pátrai | Achaia | 26504 | Greece |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| D000077554 | Levobupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
|
| Ropivacaine plain | Drug | 2.0 ml (15mg) plain ropivacaine 0.75% intrathecally |
|
|
| Levobupivacaine plain | Drug | 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally |
|
|
| bupivacaine plain +fentanyl | Drug | 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally |
|
|
| ropivacaine plain +. fentanyl | Drug | 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally |
|
|
| Levobupivacaine plain +fentanyl | Drug | 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally |
|
|
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |