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

Not Applicable
Completed
Conditions
Upper Extremity Injury Trauma
Interventions
Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Device: Echogenic needle - Pajunk sonoplex echogenic needle
Registration Number
NCT02862041
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group NonechogenicNon Echogenic needle - Stimuplex Braun Nonechogenic needleNon echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle
Group EchogenicEchogenic needle - Pajunk sonoplex echogenic needleUltrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle
Primary Outcome Measures
NameTimeMethod
Needle tip and shaft visibilityDuration of Block procedure

Percentage Needle Tip \& shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time\*100

Secondary Outcome Measures
NameTimeMethod
Duration of block procedure5- 15 minutes. Start of skin puncture till the final needle removal
Duration of sensory blockade0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
Time to onset of sensory blockade0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.
Time to onset of motor blockade0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
Block success rate of echogenic and Nonechogenic group.Duration of surgery
Duration of motor blockade0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
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