Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy

Study Overview
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Brief Summary
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This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects

Official Title
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Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy

Conditions
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Knee Arthroscopy, Spinal Anesthesia

Intervention / Treatment
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* Drug: Isobaric 2-chloroprocaine
* Drug: Hyperbaric prilocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology physical status (ASA) ≤ III Age 18-80 year Height between 160 and 185 cm Signed informed consent obtained prior to any study specific assessments and procedures Exclusion Criteria: Cardiac pathology (such as Heart failure, Aortic stenosis) Coagulation disorders (INR>1.3, platelet < 80 000/mm3) Known allergy to local anaesthetics Disagreement of the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Isobaric 2-chloroprocaine<br>The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy | Drug: Isobaric 2-chloroprocaine<br>* intrathecal injection of 50 mg isobaric 2-Chloroprocaine<br>* Other names: Ampres;|
| Active Comparator: Hyperbaric prilocaine 2%<br>The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy | Drug: Hyperbaric prilocaine<br>* intrathecal injection of 50 mg hyperbaric prilocaine 2%<br>* Other names: Tachipri;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block | Until complete release of sensory block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time of sensory block | The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold. | up to 30 minutes | 
| Onset time of motor block | The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked). | up to 30 minutes | 
| Duration of motor block | Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block | Until complete regression of motor block | 
| Pain assessed by Visual Analog Scale | Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable). | up to 24 hours | 
| Side-effects (hypotension, bradycardia, urinary retention) | Assessed during and after intervention | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local Anaesthetic, spinal anesthesia, Knee arthroscopy