Clinical trial NCT01303107: Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cesarean Delivery
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
name: Irmandade da Santa Casa da Misericórdia de Santos
First posted: 2011-02-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: latency of sensitive block at T6
timeFrame: loss of pain in T6
Secondary outcomes:
measure: duration of the anesthesia
timeFrame: recovery of the sensibility
measure: Degree of motor block
timeFrame: End of motor block
measure: maximal level of the sensitive blockade
timeFrame: last level of sensitive blockade
measure: Maternal cardiocirculatory and respiratory parameters
timeFrame: During the study
measure: Parturients ambulation
timeFrame: regression of the motor blockade
measure: Visceral pain
timeFrame: suture of the peritoneum
measure: Neonatal repercussions
timeFrame: birth of the neonatal
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Irmandade da Santa Casa da Misericórdia de Santos
state: São Paulo
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericóridia de São Paulo
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Liga Mathias, PhD
role: PRINCIPAL_INVESTIGATOR
References: