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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 4

Conditions: Patients Undergoing Lower Limb Surgery

Treatments: Drug: lévobupivacaïne; Drug: ropivacaïne

Study type: Interventional

Funder types: Other

Identifiers

NCT01935596

PI09-PR-DUPONT

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

ropivacaïne 0,5%,

Active Comparator group

Description:

intrathecal administration of 15mg of ropivacaine 0.5%.

Treatment:

Drug: ropivacaïne

lévobupivacaïne 0,5%

Active Comparator group

Description:

intrathecal administration of 15mg of levobupivacaine 0.5%

Treatment:

Drug: lévobupivacaïne