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The Sponsor has no interest in continuing the study.
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| Name | Class |
|---|---|
| Irmandade da Santa Casa de Misericordia de Sao Paulo | OTHER |
| Irmandade da Santa Casa da Misericórdia de Santos | UNKNOWN |
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The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine S50:R50 | Active Comparator | 3 ml subarachnoid block |
|
| bupivacaine S75:R25 | Experimental | 3 ml for subarachnoid block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | single dose of 15 mg by a slow injection rate of 1 mL/s |
|
| Measure | Description | Time Frame |
|---|---|---|
| latency of sensitive block at T6 | The anesthesiologist will evaluate the loss of pain to pin-prick in T10. | loss of pain in T6 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of the anesthesia | Time to recover the sensibility due to the anesthetic | recovery of the sensibility |
| Degree of motor block | Evaluated by the Bromage scale after the injection of the anesthetic solution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liga Mathias, PhD | Irmandade da Santa Casa de Misericórdia de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandade da Santa Casa da Misericórdia de Santos | Santos | São Paulo | Brazil | |||
| Irmandade da Santa Casa de Misericóridia de São Paulo |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| End of motor block |
| maximal level of the sensitive blockade | Evaluation by pin-prick every 2 minutes after the injection of the anesthetic solution. | last level of sensitive blockade |
| Maternal cardiocirculatory and respiratory parameters | systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study | During the study |
| Parturients ambulation | Will be measured the time that the parturients ambulate, due to de regression of the motor blockade | regression of the motor blockade |
| Visceral pain | Visceral pain will be assessed at the time of suture of the peritoneum. | suture of the peritoneum |
| Neonatal repercussions | Evaluation of the Apgar index in the first and fifth minutes. | birth of the neonatal |
| São Paulo |
| São Paulo |
| Brazil |
| D000588 |
| Amines |