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

Orthopedic Disorder of Spine Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Spinal Diseases

• NCT number: NCT01994967
• Study type: Interventional
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2016
• Completion date: January 2017