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

Primary Purpose

Upper Extremity Injury Trauma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echogenic needle - Pajunk sonoplex echogenic needle
Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Extremity Injury Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group Echogenic

    Group Nonechogenic

    Arm Description

    Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Duration of block procedure
    Time to onset of sensory blockade
    Time to onset of motor blockade
    Duration of sensory blockade
    Duration of motor blockade
    Block success rate of echogenic and Nonechogenic group.

    Full Information

    First Posted
    June 28, 2016
    Last Updated
    August 9, 2016
    Sponsor
    Postgraduate Institute of Medical Education and Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02862041
    Brief Title
    Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
    Official Title
    Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Medical Education and Research

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Extremity Injury Trauma

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Echogenic
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle
    Arm Title
    Group Nonechogenic
    Arm Type
    Placebo Comparator
    Arm Description
    Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle
    Intervention Type
    Device
    Intervention Name(s)
    Echogenic needle - Pajunk sonoplex echogenic needle
    Intervention Description
    Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
    Intervention Type
    Device
    Intervention Name(s)
    Non Echogenic needle - Stimuplex Braun Nonechogenic needle
    Intervention Description
    Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
    Primary Outcome Measure Information:
    Title
    Needle tip and shaft visibility
    Description
    Percentage Needle Tip & shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100
    Time Frame
    Duration of Block procedure
    Secondary Outcome Measure Information:
    Title
    Duration of block procedure
    Time Frame
    5- 15 minutes. Start of skin puncture till the final needle removal
    Title
    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.
    Title
    Time to onset of motor blockade
    Time Frame
    0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
    Title
    Duration of sensory blockade
    Time Frame
    0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
    Title
    Duration of motor blockade
    Time Frame
    0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
    Title
    Block success rate of echogenic and Nonechogenic group.
    Time Frame
    Duration of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vinoth kumar, MD
    Organizational Affiliation
    Postgraduate Institute of Medical Education and Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21425515
    Citation
    Hebard S, Hocking G. Echogenic technology can improve needle visibility during ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):185-9. doi: 10.1097/aap.0b013e31820d4349.
    Results Reference
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    PubMed Identifier
    23869186
    Citation
    Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gursoy S, Ozturk H, Mimaroglu C. The importance of needle echogenity in ultrasound guided axillary brachial plexus block: a randomized controlled clinical study. Int J Med Sci. 2013 Jul 4;10(9):1108-12. doi: 10.7150/ijms.6598. Print 2013.
    Results Reference
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    Learn more about this trial

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

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