Cesarean Delivery
Conditions
Brief summary
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
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).
Interventions
DRUGBupivacaine
single dose of 15 mg by a slow injection rate of 1 mL/s
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
Irmandade da Santa Casa da Misericórdia de Santos
Cristália Produtos Químicos Farmacêuticos Ltda.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| latency of sensitive block at T6 | loss of pain in T6 | The anesthesiologist will evaluate the loss of pain to pin-prick in T10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of motor block | End of motor block | Evaluated by the Bromage scale after the injection of the anesthetic solution |
| maximal level of the sensitive blockade | last level of sensitive blockade | Evaluation by pin-prick every 2 minutes after the injection of the anesthetic solution. |
| Maternal cardiocirculatory and respiratory parameters | During the study | systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study |
| duration of the anesthesia | recovery of the sensibility | Time to recover the sensibility due to the anesthetic |
| Visceral pain | suture of the peritoneum | Visceral pain will be assessed at the time of suture of the peritoneum. |
| Neonatal repercussions | birth of the neonatal | Evaluation of the Apgar index in the first and fifth minutes. |
| Parturients ambulation | regression of the motor blockade | Will be measured the time that the parturients ambulate, due to de regression of the motor blockade |
Countries
Brazil
Outcome results
None listed