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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Injury Trauma
• Intervention / Treatment: Device: Echogenic needle - Pajunk sonoplex echogenic needle; Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Vinoth kumar, MD, Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries
• Other Study ID Numbers: NK/1609/MD/10109-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED