Plasma Concentration of Lidocaine and Bupivacaine Axillary BPB Mixture Solutions [PCLBAxMix]

Study Overview
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Brief Summary
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The doses of local anesthetics can be decreased with the use of ultrasound guidance. In case of using mixture solutions the benefits and drawbacks are controversial. The plasma concentrations were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how lidocaine change the plasma concentration of bupivacaine after axillary approach to brachial plexus employed with different dilute and mixed solutions for upper limb surgery in trauma patients.

Detailed Description
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Total of 30 American Society of Anesthesiologist (ASA) I-III adult patients scheduled to elective or emergency trauma surgery of hand and forearm under ultrasound-guided (UG) brachial plexus block (BPB) are planned to be assigned into this randomized-prospective observational study after approval by the University Research Ethics Board, Pécs University Medical School, Hungary. All of the patients will receive detailed information about the planned BPB techniques and surgeries, then written informed consents will be obtained. Study participants are planned to be assigned randomly by the research coordinator into 3 groups (Lidocaine, Bupivacaine and mixture solution) according to the concentration of lidocaine and bupivacaine in the mixture solution. Standardized UG Axillary-supraclavicular (AX-SC) approach to the BP is planned to be performed under sterile conditions by the same anesthesiologist. The standardized dose is 0.4 ml/kg with the targeted maximized the single-shot volume of 30 ml. Blood samples will be taken at 0-time point (straight after the administration of BP injection) and 30, 60, 240 and 480 minutes after. Plasma concentrations are determined, the results are collected and analyzed. Under standard monitorization, vital parameters, data are collected on the onset time and duration of actions of local anesthetics (LAs).

Official Title
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Comparison of Plasma Concentrations of Lidocaine and Bupivacaine After Ultrasound-guided Axillary Approach to Brachial Plexus Block Used With Different Dilute Mixture Solutions for Upper Limb Trauma Surgery

Conditions
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Arm Injury

Intervention / Treatment
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* Drug: Lidocaine brachial plexus block
* Drug: Bupivacaine brachial plexus block
* Drug: Mixture brachial plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unpremedicated patient scheduled for elective or emergency trauma surgery of hand and forearm under ultrasound-guided BPB Exclusion Criteria: continuous peripheral nerve catheter technique or bilateral block was planned, or the patient refused to participate. Exclusion criteria included psycho-mental conditions interfering with consent or assessment; pre-existing chronic pain condition or daily analgesic or sedative consumption; sedative or analgesic premedication; pre-existing neurological disorders aﬀecting the brachial plexus.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study participants n=10 in the L group, n=10 in the B group and n=10 in the mixture group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Lidocaine brachial plexus block 0.4 ml/kg of 0.66% solution | Drug: Lidocaine brachial plexus block<br>* Combined Axillary-supraclavicular approach to brachial plexus with lidocaine<br>* Other names: Lidocain-EGIS 1% OGYI-T-3047/03;|
| Active Comparator: Bupivacaine<br>Bupivacaine brachial plexus block 0.4 ml/kg of 0.33% solution | Drug: Bupivacaine brachial plexus block<br>* Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine<br>* Other names: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14;|
| Active Comparator: Mixture<br>Mixture brachial plexus block 0.4 ml/kg of 0.33% bupivacaine and 0.33% lidocaine solution | Drug: Mixture brachial plexus block<br>* Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%<br>* Other names: Lidocain-EGIS 1% and Marcaine 5 mg/ml Astra Zeneca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal plasma concentrations | Plasma concentrations of bupivacaine and lidocaine 0-8 hours after injection | 0-8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset times | Onset times of local anesthetics | 0-0.5 hours | 
| Duration | Duration of actions of local anesthetics | 1-24 hours |