Concentration-Volume Relationship in Infraclavicular Block

Study Overview
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Brief Summary
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This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups

Detailed Description
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Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.

Official Title
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Impact of Local Anesthetic Concentration-Volume Modifications on Ultrasound Guided Infraclavicular Nerve Block Effectiveness

Conditions
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Brachial Plexus Blockade

Intervention / Treatment
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* Drug: Bupivacaine 0.25%
* Drug: Prilocaine 1%
* Procedure: Infraclavicular Nerve Block
* Drug: Bupivacaine 0.167%
* Drug: Bupivacaine 0.125%
* Drug: Prilocaine 0.66%
* Drug: Prilocaine 0.5%
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for upper extremity surgery with infraclavicular nerve block Exclusion Criteria: Patient Refusal Patients younger than 18 Patients with known local anesthetic allergies Patients with a BMI>30 Diabetic Patients Uncooperated Patients Patients with coagulopathy or recieving anticoagulant therapy Skin infection on injection site Patients diagnosed with sepsis or bacteremia Physiologic and emotional lability Surgeries that are expected to last longer than 3 hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concentrated<br>Infraclavicular nerve block under guidance of ultrasonography will be performed using an undiluted solution of 45mg bupivacaine and 180mg prilocaine (bupivacaine 0.25% and prilocaine 1%, 18mL in total) to patients in this group | Drug: Bupivacaine 0.25%<br> <br> * Other names: Marcaine;Drug: Prilocaine 1%<br> <br> * Other names: Citanest;Procedure: Infraclavicular Nerve Block<br>* Ultrasound guided infraclavicular nerve block<br>Device: Ultrasound<br>* All nerve blocks will be performed with ultrasound guidance<br>|
| Active Comparator: Diluted by 33%<br>Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 33% (bupivacaine 0.167% and prilocaine 0.66%, 27mL in total) to patients in this group | Procedure: Infraclavicular Nerve Block<br>* Ultrasound guided infraclavicular nerve block<br>Drug: Bupivacaine 0.167%<br> <br> * Other names: Marcaine;Drug: Prilocaine 0.66%<br> <br> * Other names: Citanest;Device: Ultrasound<br>* All nerve blocks will be performed with ultrasound guidance<br>|
| Active Comparator: Diluted by 50%<br>Infraclavicular nerve block under guidance of ultrasonography will be performed using a solution of 45mg bupivacaine and 180mg prilocaine diluted by 50% (bupivacaine 0.125% and prilocaine 0.5%, 36mL in total) to patients in this group | Procedure: Infraclavicular Nerve Block<br>* Ultrasound guided infraclavicular nerve block<br>Drug: Bupivacaine 0.125%<br> <br> * Other names: Marcaine;Drug: Prilocaine 0.5%<br> <br> * Other names: Citanest;Device: Ultrasound<br>* All nerve blocks will be performed with ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory Block, as assessed by hollman scale for pinprick test | Sensorial response to pinprick will be assessed at innervation sites of ulnar median radial and musculocutaneous nerves. Innervation sites of assessment are volar skin of the fifth finger for ulnar nerve, volar skin of second finger for median nerve and dorsal, proximal of the second finger for radial nerve and skin of the anterolateral forearm for musculocutaneous nerve. | 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute | 
| Motor Block, as assessed by hollman scale for motor blockade | Motor function for each nerve will be assessed. Movements to be evaluated are; abduction of the fingers for ulnar nerve, thumb opposition for median nerve, extension of the forearm for radial nerve and flexion of the forearm for musculocutaneous nerve. | 0, 3rd, 6th, 9th, 12th, 20th, 25th, 30th minute | 
| Postoperative Sensory Block, as assessed by hollman scale for pinprick test |  | 1th hour in PACU | 
| Postoperative Motor Block, as assessed by hollman scale for motor blockadet |  | 1th hour in PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, as assessed by visual analogue scale | In addition, patients' first complaint time of pain will be recorded by nurse | 1st hour and 6th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local Anesthtetics, Nerve Block, Bupivacaine, Prilocaine