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

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborator: Newco Trials Pesquisa Científica Ltda
• Treatments: Anesthetics; Bupivacaine; Levobupivacaine

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.