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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994967
Recruitment Status : Withdrawn (Another regulatory way was defined.)
First Posted : November 26, 2013
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Newco Trials Pesquisa Científica Ltda
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Time of latency to achieve sensitive block of T10. [ Time Frame: 01 day. ]
    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. ]
    Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Evaluation of latency to the sensory block of T10. [ Time Frame: 01 day. ]
    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.
  • Evaluation of duration to the sensory block of T10. [ Time Frame: 01 day. ]
    Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Sensory block intensity. [ Time Frame: 02 days. ]
    Ability of the patient to move their lower limbs, assessed by Bromage scale.
  • Motor block duration. [ Time Frame: 02 days. ]
    Time interval between the end of anesthetic injection and the return to 0 score in modified Bromage scale.
  • Cardiovascular safety. [ Time Frame: 02 days. ]
    Incidence and severity of hemodynamic (BP and HR) and respiratory (SpO2) alterations.
  • Block failure. [ Time Frame: 02 days. ]
    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. ]
    To evaluate the occurrence of adverse events regarding the frequency, duration, severity and causal relationship with the study medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Evaluation of the motor block degree. [ Time Frame: 02 days. ]
    Ability of the patient to move their lower limbs, assessed by Bromage scale.
  • Evaluation of motor block duration. [ Time Frame: 02 days. ]
    Time interval between the end of anesthetic injection and the return to 0 score in modified Bromage scale.
  • Evaluation of cardiovascular safety. [ Time Frame: 02 days. ]
    Incidence and severity of hemodynamic (BP and HR) and respiratory (SpO2) alterations.
  • Block failure. [ Time Frame: 02 days. ]
    To evaluate the absence of signs of analgesia or motor block for at least 20 minutes after anesthetic injection in the sensitive region studied.
  • Observation of adverse events. [ Time Frame: 02 days. ]
    To evaluate the occurrence of adverse events regarding the frequency, duration, severity and causal relationship with the study medication.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

Objectives:

Primary:

  • Evaluation of latency to sensory block of T10.
  • Evaluation of the duration of sensory block.

Secondary:

  • Evaluation of the motor block degree.
  • Evaluation of motor block duration.
  • Evaluation of cardiovascular safety.
  • Block failure.
  • Observation of adverse events.

Study Plan:

  • Estimated 120 research participants;
  • Aged between 18 - 80 in both gender;
  • Drug Intervention: 01 day

Evaluations during Trial:

  • Classification of anesthetic risk: Class I to VI by the American Society of Anesthesiologists(ASA);
  • Identification of the Anesthetic Failure;
  • Latency time for sensory block at T10;
  • Duration of sensory block and motor block;
  • Bromage scale;
  • Cardiovascular safety;

Retention of Records:

The investigator shall retain all documentation of the study over a period of at least five years from the end of the study. The Sponsor or its designee will provide a list of all documentation which should be kept by the Investigator.

Monitoring:

All aspects of the study will be carefully monitored by Cristália Pharmaceutical Chemicals Ltda. or designated representative of it (Clinical Research Organization - CRO) for evaluations related to good clinical practice and applicable local regulations.

Case Report Forms. The Monitor will be available if the investigator, or other person of his team, needs information and guidance.

The Monitor of the study should have permanent access to all documentation and it is his obligation to ensure that the Case Report Forms are complete and completed correctly, as well as checking if the data are described according to the source documents, in order to eliminate interferences that may compromise the accuracy of the data generated in the clinical trial.

Audit and Inspections:

Authorized representatives of the Sponsor or designees, regulatory authority or the Ethics Committee of the institution may conduct audits or inspections during or after the study conclusion.

Collecting Data:

The information corresponding to the data of interest from the study will be collected and recorded in Case Report forms provided by Sponsor, and filled from the information contained in the source documents.

Documents are considered sources for study: medical records used by the professional at the time of the visits, diagnostic tests or image.

Informed Consent of Trial:

The Principal Investigator will ensure that the research participant receive verbally and in writing all relevant information about the nature, purpose, the test drug, the possible risks and benefits of the study.

Research participants will be notified that they are free to discontinue the study at any time. That they will have the opportunity to ask questions and to have sufficient time to consider the information received.

Formation of the database:

The database of the study will be assembled with the data from the Case Report Forms. Doubts and discrepancies will generate questions (queries) written to the Principal Investigator.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Orthopedic Disorder of Spine
Intervention  ICMJE
  • Drug: Levobupivacaine
    Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
    Other Name: Levobupivacaine Hydrochloride.
  • Drug: Bupivacaine
    Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
    Other Names:
    • Neocaína ®.
    • Bupivacaine Hydrochloride.
Study Arms  ICMJE
  • Experimental: Levobupivacaine

    Presentation: injectable solution - ampoule of Levobupivacaine Hydrochloride

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

    Intervention: Drug: Levobupivacaine
  • Active Comparator: Bupivacaine

    Presentation: injectable solution - ampoule of Bupivacaine Hydrochloride

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

    Intervention: Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 18, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
120
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994967
Other Study ID Numbers  ICMJE CRT074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristália Produtos Químicos Farmacêuticos Ltda.
Study Sponsor  ICMJE Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborators  ICMJE Newco Trials Pesquisa Científica Ltda
Investigators  ICMJE
Principal Investigator: Onésimo D. Ribeiro Junior, Medic CEMEC
PRS Account Cristália Produtos Químicos Farmacêuticos Ltda.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP