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Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.

Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01308047
Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo (Other), Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo (Other)
0
Enrollment
2
Locations
2
Arms
0
Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.

This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.

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:
Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

Arms and Interventions

Arm Intervention/Treatment
Experimental: bupivacaine S75:R25

3 ml for subarachnoid block

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

    		•
    Active Comparator: bupivacaine (S50:R50)

    3 ml subarachnoid block

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time of latency for sensory block at T10 dermatome. [+/- 40 min after injection]

      Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.

    Secondary Outcome Measures

    1. Sensory block duration [+/- 3 hours]

      Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot.

    2. Motor Block Evaluation [+/- 30 min]

      Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.

    3. Maximum cranial dispersion verifying the largest metamer achieved. [+/- 45 min]

      Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time.

    4. Evaluation of the cardiocirculatory and respiratory parameters [+/- 8 hours]

      Systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study to measure the safety of cardiocirculatory and respiratory parameters

    5. Time of regression of motor block by Bromage Scale [+/- 9 - 10 hours]

      Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale

    6. The residual analgesic effect [+/- 9-10 hours]

      Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication.

    7. Anesthetic failure [+/- 45 min]

      Evaluation of the anesthetic failure (if occur)

    8. Adverse Events [+/- 8 - 12 hours]

      During the study will be evaluate the presence of adverse event due to the anesthetic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ASA (American Society of Anesthesiologists) I or ASA II

    • Spinal Anaesthesia for lower limb surgery

    • Patient Consent

    Exclusion Criteria:

    • relative or absolute contraindications for spinal anesthesia

    • history of hypersensitivity to the local anesthetics or components

    • opioids for anesthetic adjuvant

    • spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity

    • Body mass index = or > 35

    • lumbar puncture difficulty

    • ventricular extrasystoles

    • dementia, others loss of cognitive ability

    • difficulty in the spine

    • spinal cord surgery

    • anaphylactic reactions or Stevens-johnson Syndrome

    • polytraumatism

    • alcoholism abuse and use of illicit substance

    • Changes in the blood test

    • Others conditions judged by investigator's opinion

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Cristália Produtos Químicos Farmacêuticos Ltda.
    • Irmandade da Santa Casa de Misericordia de Sao Paulo
    • Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo

    Investigators

    • Principal Investigator: Ligia 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:
    NCT01308047
    Other Study ID Numbers:
    • CRIST016
    First Posted:
    Mar 3, 2011
    Last Update Posted:
    Mar 26, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    No Results Posted as of Mar 26, 2014