Clinical trial NCT01935596: Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
Official title: Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Lower Limb Surgery
Keywords: Anesthesia
Randomized study
Lower limbs surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: duration of anesthesia on sensitivity
timeFrame: during 6h after induction
Secondary outcomes:
measure: Duration of anesthesia on motor block
timeFrame: during 6h after induction
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hervé DUPONT
state: Picardie
Study officials:
affiliation: CHU Amiens France
name: Hervé DUPONT, Professor
role: STUDY_DIRECTOR
References: