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

This study has been withdrawn prior to enrollment.
(The Sponsor has no interest in continuing the study.)
Sponsor:
Collaborators:
Irmandade da Santa Casa de Misericordia de Sao Paulo
Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01308047
First received: February 23, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Fracture of Lower Limb
Drug: Bupivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • Time of latency for sensory block at T10 dermatome. [ Time Frame: +/- 40 min after injection ] [ Designated as safety issue: No ]
    Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.


Secondary Outcome Measures:
  • Sensory block duration [ Time Frame: +/- 3 hours ] [ Designated as safety issue: No ]
    Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot.

  • Motor Block Evaluation [ Time Frame: +/- 30 min ] [ Designated as safety issue: No ]
    Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.

  • Maximum cranial dispersion verifying the largest metamer achieved. [ Time Frame: +/- 45 min ] [ Designated as safety issue: No ]
    Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time.

  • Evaluation of the cardiocirculatory and respiratory parameters [ Time Frame: +/- 8 hours ] [ Designated as safety issue: No ]
    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

  • Time of regression of motor block by Bromage Scale [ Time Frame: +/- 9 - 10 hours ] [ Designated as safety issue: No ]
    Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale

  • The residual analgesic effect [ Time Frame: +/- 9-10 hours ] [ Designated as safety issue: No ]
    Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication.

  • Anesthetic failure [ Time Frame: +/- 45 min ] [ Designated as safety issue: No ]
    Evaluation of the anesthetic failure (if occur)

  • Adverse Events [ Time Frame: +/- 8 - 12 hours ] [ Designated as safety issue: No ]
    During the study will be evaluate the presence of adverse event due to the anesthetic.


Enrollment: 0
Arms Assigned Interventions
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 Name: 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 Name: marcaine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308047

Locations
Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Hospital Sepaco
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
  More Information

No publications provided

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01308047     History of Changes
Other Study ID Numbers: CRIST016
Study First Received: February 23, 2011
Last Updated: March 25, 2014
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014