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Completed

NCT Number: NCT02862041

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echogenic needle - Pajunk sonoplex echogenic needle

Device

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Non Echogenic needle - Stimuplex Braun Nonechogenic needle

Device

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Primary outcomes

  1. Needle tip and shaft visibility

    Time frame: Duration of Block procedure

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

Secondary outcomes

  1. Duration of block procedure

    Time frame: 5- 15 minutes. Start of skin puncture till the final needle removal

  2. Time to onset of sensory blockade

    Time frame: 0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.

  3. Time to onset of motor blockade

    Time frame: 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.

  4. Duration of sensory blockade

    Time frame: 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.

  5. Duration of motor blockade

    Time frame: 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.

  6. Block success rate of echogenic and Nonechogenic group.

    Time frame: Duration of surgery

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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