Axillary Approach to Brachial Plexus Blockade Using Ketamine, Regional Versus Intravenous Administration

Study Overview
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Brief Summary
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The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.

Detailed Description
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After being informed about the study, patients giving written informed consent will undergo anaesthesia using the Ultrasound Guided Axillary Approach to Brachial Plexus Blockade, in order to undergo forearm surgery. The purpose of this study is to assess whether Ketamine as an adjuvant lengthens sensory and motor blockade and whether it has an effect on rebound pain when the anaesthetic effect fades. Therefore the study will compare intravenous, regional and no administration of Ketamine as an adjuvant to Branchial Plexus Blockade. Patients will be asked to fill in a Pain VAS (Visual Analog Scale) for 24 hours following the intervention, in order to assess effectiveness of each anaesthetic method. Side effects, onset time, motor blockade score and rescue dose are also recorded.

Official Title
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Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study

Conditions
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Branchial Plexus Blockade, Anesthesia

Intervention / Treatment
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* Procedure: Forearm surgey
* Drug: Ropivacaine
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 20-35 ASA score I, II, III Exclusion Criteria: Mental disorder Peripheral neuropathy Severe hepatic or renal disease Gastrointestinal bleeding history

Ages Eligible for Study
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Minimum Age: 16 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant. | Procedure: Forearm surgey<br>* Microsurgery Clinic , KAT Hospital Athens<br>Drug: Ropivacaine<br>* Ropivacaine<br>|
| Active Comparator: Ketamine IV<br>Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously. | Procedure: Forearm surgey<br>* Microsurgery Clinic , KAT Hospital Athens<br>Drug: Ropivacaine<br>* Ropivacaine<br>Drug: Ketamine<br>* Ketamine<br>|
| Active Comparator: Ketamine Regional<br>Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally. | Procedure: Forearm surgey<br>* Microsurgery Clinic , KAT Hospital Athens<br>Drug: Ropivacaine<br>* Ropivacaine<br>Drug: Ketamine<br>* Ketamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analog Scale) over 24 hours following intervention | VAS scale is expressed in integer numbers ranging from 0-10, where 0=no pain, 10= excruciating pain. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects | Dizziness, nausea, vomiting, paraesthesia | 24 hours | 
| Motor Blockade Score | 0=complete paralysis, 1=partial paralysis, 2=no paralysis | 24 hours | 
| Anesthesia Onset time | Time from removal of needle to final motor and sensory blockade result | 24 hours | 
| Rescue Dose | Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary Approach, Ketamine, Adjuvant