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

Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01303107
Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo (Other), Irmandade da Santa Casa da Misericórdia de Santos (Other)
0
Enrollment
2
Locations
2
Arms
0
Patients Per Site

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
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

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: bupivacaine S50:R50

3 ml subarachnoid block

Drug: Bupivacaine
single dose of 15 mg by a slow injection rate of 1 mL/s
Other Names:
  • Marcaine

    		•
    Experimental: bupivacaine S75:R25

    3 ml for subarachnoid block

    Drug: Bupivacaine
    single dose of 15 mg by a slow injection rate of 1 mL/s
    Other Names:
  • Marcaine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. duration of the anesthesia [recovery of the sensibility]

      Time to recover the sensibility due to the anesthetic

    2. Degree of motor block [End of motor block]

      Evaluated by the Bromage scale after the injection of the anesthetic solution

    3. 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.

    4. 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

    5. Parturients ambulation [regression of the motor blockade]

      Will be measured the time that the parturients ambulate, due to de regression of the motor blockade

    6. Visceral pain [suture of the peritoneum]

      Visceral pain will be assessed at the time of suture of the peritoneum.

    7. Neonatal repercussions [birth of the neonatal]

      Evaluation of the Apgar index in the first and fifth minutes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Irmandade da Santa Casa da Misericórdia de Santos Santos São Paulo Brazil
    2 Irmandade da Santa Casa de Misericóridia de São Paulo São Paulo Brazil

    Sponsors and Collaborators

    • Cristália Produtos Químicos Farmacêuticos Ltda.
    • Irmandade da Santa Casa de Misericordia de Sao Paulo
    • Irmandade da Santa Casa da Misericórdia de Santos

    Investigators

    • Principal Investigator: Liga Mathias, PhD, Irmandade da Santa Casa de Misericórdia de São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cristália Produtos Químicos Farmacêuticos Ltda.
    ClinicalTrials.gov Identifier:
    NCT01303107
    Other Study ID Numbers:
    • CRIST019
    First Posted:
    Feb 24, 2011
    Last Update Posted:
    Mar 26, 2014
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    No Results Posted as of Mar 26, 2014