Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

Study Overview
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Brief Summary
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The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.

Detailed Description
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The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics are used frequently in this setting. Lidocaine is one of the agents that is used most frequently. It has been associated with an increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that is being used more often and is said to act faster and shorter than lidocaine. We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind clinical trial. Endpoint are: onset of sensory and motor block recovery from sensory and motor block time to micturition patient satisfaction complications

Official Title
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Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery: A Double Blind Randomized Clinical Trial.

Conditions
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Spinal Anesthesia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years ASA I-III Patients planned for a short surgical procedure on lower extremities or lower abdomen. Procedure in day-case setting Procedure under spinal anesthesia Informed consent Exclusion Criteria: Contra-indications spinal anesthesia History of allergic reactions on amide-type local anesthetics Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine<br> | Drug: spinal administration of lidocaine<br> <br> |
| Experimental: articaine<br> | Drug: spinal administration of articaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time (sec) of sensory and motor blockade (after administration of drug) |  |  | 
| Recovery time (min) from sensory and motor blockade |  |  | 
| Spread of sensory blockade (30 min after administration of drug, dermatomal level) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic stability (lowest systolic blood pressure, vasopressor therapy) |  |  | 
| Complications |  |  | 
| Patient satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, lidocaine, articaine, intrathecal