Spinal Anesthesia With Articaine and Bupivacaine for Outpatient Lower Limb Surgery

Study Overview
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Brief Summary
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The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Onset and recovery times of sensory and motor blockade will be compared.

Detailed Description
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The purpose of the trial is to compare two local anesthetics, articaine and bupivacaine for outpatient lower limb surgery. Faster onset and shorter elimination time favours a short-acting local anaesthetic for spinal anesthesia for out-patient lower limb surgery, e.g. knee arthroscopy, foot and varices surgery. Patients will recover faster and less complications will be expected. Articaine is said to act faster and shorter than a low dose of bupivacaine. There are not enough data available to establish that articaine is as safe as and more effective by outpatient lower limb surgery than bupivacaine. Spinal anesthesia with articaine will be compared to spinal anesthesia with bupivacaine in a randomized double blind clinical trial. Endpoints are: onset of sensory and motor block maximum spread of sensory level recovery from sensory and motor block time to micturition complications

Official Title
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Spinal Anesthesia With 5% Articaine and 0.5% Bupivacaine for Outpatient Lower Limb Surgery. A Double-Blind Randomised Clinical Trial

Conditions
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Spinal Anesthesia

Intervention / Treatment
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* Drug: spinal administration of articaine
* Drug: spinal administration of bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 70 years Patients planned for an outpatient lower limb surgery Procedure under spinal anesthesia Informed consent Exclusion Criteria: Contra-indications spinal anesthesia History of allergic reactions on amide-type local anesthetics Length < 1.60 m or > 1.90 m BMI < 18.5 kg/m2 or > 35 kg/m2 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: spinal administration of articaine|nan|
|Drug: spinal administration of bupivacaine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time from motor blockade |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of sensory and motor blockade |  |  | 
| maximum spread of sensory blockade (30 min after spinal injection of anesthetic) |  |  | 
| spread of sensory blockade after 1,5 hour |  |  | 
| recovery time from sensory blockade |  |  | 
| time to micturation |  |  | 
| complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, spinal, articaine, bupivacaine, outpatient, surgery, limbs