Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.

Official Title
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Effect of Epinephrine on Systemic Absorption of Mepivacaine Administered for Brachial Plexus Block in Patients With Chronic Renal Insufficiency

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Mepivacaine with epinephrine
* Drug: Plain mepivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient acceptance of regional anaesthesia Exclusion Criteria: peripheral arteriosclerosis diabetes mellitus bleeding disorder infection at the puncture site allergy to mepivacaine pregnancy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain mepivacaine<br> | Drug: Plain mepivacaine<br>* Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)<br>* Other names: Carbocain;|
| Active Comparator: Mepivacaine with epinephrine<br> | Drug: Mepivacaine with epinephrine<br>* Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL)<br>* Other names: Carbocain-Adrenalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of mepivacaine |  | 0, 5, 10, 20, 30, 45, 60, 120, and 180 min after blockade | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central circulation | Heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade | 
| Peripheral tissue oxygenation | Near infrared spectrometry obtained from the triceps muscle of the blocked arm | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 min after blockade | 
| Cardiotoxicity of local anesthetic | 12-lead ECG | 0, 5, 10, 20, 30, 45, and 60 min after blockade | 
| Neurotoxicity of local anesthetic | Visual and hearing disturbances, dysarthria, tingling, perioral numbness, dizziness, paraesthesia, muscular twitching and rigidity | Continuously for 1 hour after blockade | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mepivacaine, Epinephrine, Brachial plexus block, Renal insufficiency