NCT01308047

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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fracture of Lower Limb

Interventions

Type	Name	Description
DRUG	Bupivacaine	single dose of 15mg by a slow injection rate of 1 ml/s

Timeline

• First posted: 2011-03-03
• Last updated: 2014-03-26

Locations

2 sites across 1 country: Brazil