NCT01935596

Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.

Detailed description

Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions. Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.

Conditions

• Patients Undergoing Lower Limb Surgery

Interventions

Type	Name	Description
DRUG	ropivacaïne	spinal anesthesia.
DRUG	lévobupivacaïne

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-09-05
• Last updated: 2025-11-19

Locations

1 site across 1 country: France