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

NCT ID: NCT01935596

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-04-30

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.

Conditions

Patients Undergoing Lower Limb Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ropivacaïne 0,5%,

intrathecal administration of 15mg of ropivacaine 0.5%.

Group Type: ACTIVE_COMPARATOR

ropivacaïne

Intervention Type: DRUG

spinal anesthesia.

lévobupivacaïne 0,5%

intrathecal administration of 15mg of levobupivacaine 0.5%

Group Type: ACTIVE_COMPARATOR

lévobupivacaïne

Intervention Type: DRUG

Interventions

ropivacaïne

spinal anesthesia.

Intervention Type: DRUG

lévobupivacaïne

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé DUPONT, Professor

Role: STUDY_DIRECTOR

CHU Amiens France

Locations

Hervé DUPONT

Amiens, Picardie, France

Countries

France

References

https://www.em-consulte.com/article/998410/comparaison-de-l-efficacite-de-la-levobupivacaine-

Reference Type: RESULT

Other Identifiers

PI09-PR-DUPONT

Identifier Type: -

Identifier Source: org_study_id