Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

Study Overview
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Brief Summary
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The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. To get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach. Few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. Furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques. Therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.

Official Title
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Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.

Conditions
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Scaphoid Fractures, Distal Radius Fractures, Wrist Injury Arthrodesis

Intervention / Treatment
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* Device: Ultrasound: Axillary block
* Device: Ultrasound: Infraclavicular block
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age older than 18 years and less than 70 years consent informed signed by the patient candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis American Society of Anesthesiology physical status I, II and III body mass index (BMI) <35 kg / m². Exclusion Criteria: cognitive impairment or active psychiatric condition infection at the puncture site bleeding disorders history of allergy to ropivacaine

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound: Axillary block<br>For the axillary group, the ultrasound probe will be placed upright in the armpit to obtain a cross section of this region. After visualization of the nerves form the brachial plexus by ultrasound, 5 mL of ropivacaine 0.5% will be injected around each nerve to be blocked (median, ulnar, radial and musculocutaneous). If resistance to the injection of the solution is present or the patient complains of severe pain, the needle will be immediately repositioned. | Device: Ultrasound: Axillary block<br>* Ultrasound guided axillary block<br>Drug: Ropivacaine<br>* 20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)<br>|
| Active Comparator: Ultrasound: Infraclavicular block<br>For the infraclavicular group, the ultrasound probe will be placed in the infraclavicular region (the junction between the clavicle and the coracoid process) to obtain a cross-sectional imaging of the axillary artery. After visualization of the axillary artery by ultrasound, the block will be performed using the technique in plan for visualization of the needle. The needle is placed in position 6-8 hours of the artery, and 20 mL of ropivacaine 0.5% will be injected, observing a dispersal of local anesthetic around the artery. | Device: Ultrasound: Infraclavicular block<br>* Ultrasound guided infraclvicular block<br>Drug: Ropivacaine<br>* 20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesia | All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient. | first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local anesthetic pharmacokinetics | Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry. | During the procedure |