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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: Irmandade da Santa Casa de Misericordia de Sao Paulo; Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
• Treatments: Bupivacaine; Levobupivacaine

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