Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block

Study Overview
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Brief Summary
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In this prospective, randomized, double blinded study, the needle tip and needle shaft visibility of echogenic and nonechogenic needle were compared in ultrasound guided infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery were included in the study. Patients were randomised into two groups, group E (Echogenic) and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted.

Detailed Description
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The aim of the investigators study was to find out the better among the echogenic and nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups, Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each group. The ultrasound imaging of each nerve block was video recorded for later analysis. Recording commenced from skin puncture and stopped at the time of final needle removal (total block time). After each block the performer was asked to subjectively score the percentage time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 = 20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by an investigator. An objective measurement of percentage needle tip visibility and needle shaft visibility was calculated for each nerve block using the formula, Time in view (needle tip) / total block time x 100 Time in view (needle shaft) / total block time x 100 The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted. Other block parameters were also compared.

Official Title
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Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study

Conditions
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Upper Extremity Injury Trauma

Intervention / Treatment
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* Device: Echogenic needle - Pajunk sonoplex echogenic needle
* Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years, both male and female scheduled for upper extremity surgery Exclusion Criteria: Clinically significant coagulopathy Local anesthetic allergy Preexisting motor or sensory deficit in the operative limb Uncontrolled hypertension and unstable Ischemic Heart disease Body mass index > 35 Patients who needs general anaesthesia for surgery

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Echogenic<br>Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle | Device: Echogenic needle - Pajunk sonoplex echogenic needle<br>* Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries<br>|
| Placebo Comparator: Group Nonechogenic<br>Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle | Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle<br>* Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle tip and shaft visibility | Percentage Needle Tip & shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100 | Duration of Block procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of block procedure |  | 5- 15 minutes. Start of skin puncture till the final needle removal | 
| Time to onset of sensory blockade |  | 0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test. | 
| Time to onset of motor blockade |  | 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis. | 
| Duration of sensory blockade |  | 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively. | 
| Duration of motor blockade |  | 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions. | 
| Block success rate of echogenic and Nonechogenic group. |  | Duration of surgery |