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

Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

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.

The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.

This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.

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