Paramedian Spinal Anaesthesia : Comparison Between Land-mark Guided Technique and Real-time Ultrasound Guided Technique.

Study Overview
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Brief Summary
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To identify the value of using the ultrasound in applying a commonly used regional anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark guided approach, regarding the efficiency of the anaesthetic technique, incidence of associated common complications and patient's satisfaction.

Official Title
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Paramedian Spinal Anaesthesia for Orthopaedic Knee Surgery: Comparison Between Conventional Blind Land-mark Guided Technique and Real-time Ultrasound Guided Technique: a Randomized Controlled Trial.

Conditions
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Paramedian Spinal Anaesthesia, Real Time Ultrasound Guiding

Intervention / Treatment
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* Procedure: conventional paramedian spinal anesthesia
* Device: ultrasound guided paramedian spinal anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II patients Patient's consented approval Males or Females Aged 18-60 years old Body mass index less than 30 Scheduled for orthopaedic knee surgeries Exclusion Criteria: Age less than 18, and more than 60 years Body mass index more than 30 Patient refusal or failure to obtain consent Patient in whom spinal anaesthesia is contraindicated (infection at the site of needle insertion, coagulopathy reflected by values of INR≥ 1.2 or platelets count≤ 75.000, or receiving oral anticoagulants) Known sensitivity to local anaesthetics Pre-existing neurological disorder or neuromuscular disease Clinically obvious or known spinal deformity or previous spinal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>conventional paramedian spinal anesthesia | Procedure: conventional paramedian spinal anesthesia<br>* land mark guided paramedian spinal anesthesia<br>|
| Experimental: Ultrasound<br>ultrasound guided paramedian spinal anesthesia | Device: ultrasound guided paramedian spinal anesthesia<br>* real time ultrasound guided paramedian spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of puncture attempts |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Landmark palpation easiness score |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 
| The visibility of the ligamentum flavum-dura mater complex by the US. |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 
| Duration of the anaesthetic procedure |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 
| The incidence of paraesthesia and backache |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 
| The incidence of failure of introducing spinal anaesthesia using each of the study techniques. |  | during the time taken for introducing the regional anesthetic technique in the intraoperative period | 
| Patient's satisfaction score regarding the anaesthetic technique |  | within 2 hours in the postoperative period | 
| Post dural puncture headache (incidence-onset-duration-severity) |  | within 3 days after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paramedian spinal anesthesia, real time, ultrasound, knee surgeries, conventional