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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine; Levobupivacaine; Ropivacaine

Criteria

Inclusion Criteria:

• patient admitted to the emergency for lower limb trauma,

• age over 18 years and below 65 years

• lower limb trauma surgery can be performed under spinal anesthesia.

Exclusion Criteria:

• Refusal of patients to participate in the study,

• Patient with cons-indication to spinal anesthesia:

• Local anesthetic allergy agents (1/13000)

• bleeding disorders, including pharmacological origin

• infection at the puncture site,

• refusal of spinal anesthesia by the patient,

• Patient trust,

• Patients whose coagulation is abnormal.

• Patients with cognitive impairment or incapacitated adult,

• Multiple trauma,

• Porphyria,

• Central preexisting neuropathy,

• A history of spinal surgery,

• Epilepsy uncontrolled by treatment,

• Hypovolemia,

• Pregnant or lactating women,

• Participation in another ongoing clinical trial,

• Patient on anticoagulant therapy,

• Patient not affiliated with a social security system.