Nerve Stimulator for Patients With Upper Extremity Disease, Vascular or Orthopedic Surgery

Study Overview
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Brief Summary
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To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.

Detailed Description
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The Investigators will use the assessment of onset of motor and sensory block Q 5 minutes to distinguish the difference between blocks performed with ultrasound guidance with or without a nerve blockade monitor.

Official Title
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Does the Use of a Nerve Stimulator Improve the Outcome of Ultrasound-Guided Supraclavicular Block (Anesthesia) for Upper Extremity Surgery?

Conditions
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Other Biomechanical Lesions of Upper Extremity

Intervention / Treatment
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* Procedure: Local anesthetic block [0.35% marcaine]
* Device: Braun DIG-R-C Stimuplex Blockade Monitor System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and females 21 through 89 Agree to study participation and signed the informed consent Scheduled for upper extremity surgery with ultrasound guided supraclavicular block - Exclusion Criteria: Children Pregnant Women Persons with allergies to local anesthetics Persons with infections at or near site of needle insertion Patients with severe disturbance of cardiac rhythm and heart block Patients with severe respiratory compromise Patients requiring bilateral upper extremity anesthesia Patients with coagulopathy or medical anticoagulation Patients with traumatic nerve injury to neck or upper extremity Patients with preexisting neurological deficits in the distribution of the block Patients with previous surgery to the neck that may distort brachial plexus anatomy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Group<br>In the Standard Group, in the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered into the brachial plexus of the upper limb being operated on, at the supraclavicular level. | Procedure: Local anesthetic block [0.35% marcaine]<br>* In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered.<br>* Other names: 40 ml of local anesthetic block [0.35% marcaine];|
| Experimental: Test Group<br>In this group, the ultrasound guided local anesthetic block into the brachial plexus at the supraclavicular level of the upper limb being operated on will be supplemented by use of a blockade monitor (Nerve stimulator device) to direct final placement of the needle for the nerve block. Only this group of the patients will receive this intervention with sufficient detail so that it can be distinguished from the Test Group | Procedure: Local anesthetic block [0.35% marcaine]<br>* In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered.<br>* Other names: 40 ml of local anesthetic block [0.35% marcaine];Device: Braun DIG-R-C Stimuplex Blockade Monitor System<br>* The blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength | The investigators will be assessing changes between muscle strength in the myotomal distribution of the upper limb corresponding to the anesthetized region of the brachial plexus following supraclavicular block, using the MRC power scale (medical research council scale, 0-5), with strength values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block. | 30 minutes post block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot cold discrimination | The investigators will be assessing changes in temperature sensation in the dermatomal distribution of the upper limb corresponding to the anesthetized region of the brachial plexus following supraclavicular block, using cold alcohol wipe and recording responses on a binary scale of sensation (can or cannot feel cold stimulus), with sensory values obtained at time zero (initiation of the block), and to compared to subsequent measurements in 5 minute intervals until the final measurement at 30 minutes following the block. | 30 minutes post block |