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

Cristalia

Status and phase

Withdrawn

Phase 3

Conditions

Fracture of Lower Limb

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01308047

CRIST016

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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