Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor:
Collaborator:
Newco Trials Pesquisa Científica Ltda
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01994967
First received: October 30, 2013
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.


Condition Intervention Phase
Orthopedic Disorder of Spine.
Drug: Levobupivacaine
Drug: Bupivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study Phase III to Evaluate the Noninferiority of Heavy Levobupivacaine 50% Enantiomeric Excess (Levobupivacaine S75:R25) Compared to Racemic Heavy Bupivacaine (Bupivacaine S50:R50) in Spinal Anesthesia for Lower Limb Orthopedic Procedures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time of latency to achieve sensitive block of T10. [ Time Frame: 01 day. ] [ Designated as safety issue: No ]
    The interval of time between the withdrawal of the needle at the end of local anesthetic injection and the absence of response to sensory stimulus in the region corresponding to the T10.

  • Duration time of the sensory block of T10. [ Time Frame: 01 day. ] [ Designated as safety issue: No ]
    Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.


Secondary Outcome Measures:
  • Sensory block intensity. [ Time Frame: 02 days. ] [ Designated as safety issue: Yes ]
    Ability of the patient to move their lower limbs, assessed by Bromage scale.

  • Motor block duration. [ Time Frame: 02 days. ] [ Designated as safety issue: Yes ]
    Time interval between the end of anesthetic injection and the return to 0 score in modified Bromage scale.

  • Cardiovascular safety. [ Time Frame: 02 days. ] [ Designated as safety issue: Yes ]
    Incidence and severity of hemodynamic (BP and HR) and respiratory (SpO2) alterations.

  • Block failure. [ Time Frame: 02 days. ] [ Designated as safety issue: Yes ]
    To evaluate the absence of signs of analgesia or motor block for at least 20 minutes after anesthetic injection in the sensitive region studied.

  • Adverse events. [ Time Frame: 02 days. ] [ Designated as safety issue: Yes ]
    To evaluate the occurrence of adverse events regarding the frequency, duration, severity and causal relationship with the study medication.


Estimated Enrollment: 120
Study Start Date: December 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levobupivacaine

Presentation: injectable solution - ampoule of Levobupivacaine Hydrochloride

Indication: production of subarachnoid block (spinal/ spinal anesthesia).

Drug: Levobupivacaine
Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
Other Name: Levobupivacaine Hydrochloride.
Active Comparator: Bupivacaine

Presentation: injectable solution - ampoule of Bupivacaine Hydrochloride

Indication: production of subarachnoid block (spinal/ spinal anesthesia).

Drug: Bupivacaine
Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
Other Names:
  • Neocaína ®.
  • Bupivacaine Hydrochloride.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes;
  • Age between 18 and 80 years;
  • Risk anesthetic classified as ASA I or ASA II, according to the American Society of Anesthesiology;
  • What have indication for spinal orthopedic surgery in the lower limbs;
  • Have agreed to participate and signed the informed consent form.

Exclusion Criteria:

  • Absolute or relative contraindications to spinal anesthesia;
  • Hypersensitivity or intolerance to local anesthetics or to components of the formula;
  • Spinal cord injuries, peripheral neuropathy or other neurological condition that lead to sensitivity and/ or motor function disorder;
  • Dementia, mental retardation and others important cognitive changes;
  • Obesity with a body mass index ( BMI ) ≥ 35 or difficulty in executing the puncture;
  • Anatomical column difficulty in the opinion of the investigator;
  • Previous spine surgical intervention;
  • Polytrauma;
  • Tattoo at the puncture site;
  • Alcoholism;
  • Abuse of illicit substances;
  • Antecedents of severe anaphylactic reactions or Steven - Johnson disease;
  • Changes in security checks;
  • Participation in a clinical study in the 12 months preceding this inclusion;
  • Pregnancy and lactation;
  • Any other condition that in the opinion of the investigator, may lead to increased risk for the patient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994967

Contacts
Contact: Onésimo D. Ribeiro Junior, Medic 55 11 4930-4243 cemec.assessoria@gmail.com

Locations
Brazil
CEMEC - Multidisciplinary Center of Clinical Studies Not yet recruiting
São Paulo, Brazil, 09780-000
Contact: Onésimo D. Ribeiro Junior, Medic    55 11 4930-4243      
Principal Investigator: Onésimo D. Ribeiro Junior, Medic         
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Newco Trials Pesquisa Científica Ltda
Investigators
Principal Investigator: Onésimo D. Ribeiro Junior, Medic CEMEC
  More Information

No publications provided

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01994967     History of Changes
Other Study ID Numbers: CRT074
Study First Received: October 30, 2013
Last Updated: August 7, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Phase III
Noninferiority
Controlled
Double-blind
Randomized
Spinal
Anesthetic
Lower limb

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

ClinicalTrials.gov processed this record on August 21, 2014