Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation

Conditions
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Cesarean Delivery

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parturients at term ASA (American Society of Anesthesiologists) I or ASA II elective cesarean section with low risk labor pre-natal follow-up patient consent Exclusion Criteria: relative or absolute contraindications for spinal anesthesia history of hypersensitivity to the local anesthetics use of opioids during labor labor lasting more than 12 hours or less than 1 hour complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy. spinal lesions, peripheral neuropathies or any other neurologic disorders that lead to changes of sensitivity and/or motricity decompensated diabetes or hypertension history of alcohol and/or drug abuse cardiopathies, especially myocardiopathies and valvulopathies; important cognitive changes changes in safety exams twin pregnancy; signs of intrauterine distress, and abnormalities of fetal vitality, prematurity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: bupivacaine S50:R50<br>3 ml subarachnoid block | Drug: Bupivacaine<br>* single dose of 15 mg by a slow injection rate of 1 mL/s<br>* Other names: Marcaine;|
| Experimental: bupivacaine S75:R25<br>3 ml for subarachnoid block | Drug: Bupivacaine<br>* single dose of 15 mg by a slow injection rate of 1 mL/s<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |