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

Phase 4

Completed

• Conditions: Patients Undergoing Lower Limb Surgery
• Interventions: Drug: ropivacaïne; Drug: lévobupivacaïne

• Registration Number: NCT01935596
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-23
• Study Start: 2013-05
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaïne 0,5%,	ropivacaïne	intrathecal administration of 15mg of ropivacaine 0.5%.
lévobupivacaïne 0,5%	lévobupivacaïne	intrathecal administration of 15mg of levobupivacaine 0.5%

Primary Outcome Measures

Name	Time	Method
duration of anesthesia on sensitivity	during 6h after induction	Thermo-algesic exploration of sensitivity through the application of an ice cube

Secondary Outcome Measures

Name	Time	Method
Duration of anesthesia on motor block	during 6h after induction

Trial Locations

Locations (1)

Hervé DUPONT; 🇫🇷 Amiens, Picardie, France