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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Upper Extremity Injury Trauma

Treatments: Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle; Device: Echogenic needle - Pajunk sonoplex echogenic needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02862041

NK/1609/MD/10109-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group Echogenic

Active Comparator group

Description:

Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle

Treatment:

Device: Echogenic needle - Pajunk sonoplex echogenic needle

Group Nonechogenic

Placebo Comparator group

Description:

Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle

Treatment:

Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle