Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5% (ROPI-LEVO)

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%.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Lower Limb Surgery
• Intervention / Treatment: Drug: ropivacaïne; Drug: lévobupivacaïne

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Hervé DUPONT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaïne 0,5%,; intrathecal administration of 15mg of ropivacaine 0.5%.	Drug: ropivacaïne; spinal anesthesia.
Active Comparator: lévobupivacaïne 0,5%; intrathecal administration of 15mg of levobupivacaine 0.5%	Drug: lévobupivacaïne

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of anesthesia on sensitivity	Thermo-algesic exploration of sensitivity through the application of an ice cube	during 6h after induction

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of anesthesia on motor block	during 6h after induction

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Study Director: Hervé DUPONT, Professor, CHU Amiens France

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Anesthesia; Randomized study; Lower limbs surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: PI09-PR-DUPONT