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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

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).

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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).

Conditions

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Cesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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bupivacaine S50:R50

3 ml subarachnoid block

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

single dose of 15 mg by a slow injection rate of 1 mL/s

bupivacaine S75:R25

3 ml for subarachnoid block

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

single dose of 15 mg by a slow injection rate of 1 mL/s

Interventions

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Bupivacaine

single dose of 15 mg by a slow injection rate of 1 mL/s

Intervention Type DRUG

Other Intervention Names

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Marcaine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes