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

Upper Extremity Injury Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862041
• Other study ID #: NK/1609/MD/10109-10
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: August 9, 2016
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Arm Injuries
• Upper Extremity Injury Trauma

Intervention

Device:
• Echogenic needle - Pajunk sonoplex echogenic needle
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
• Non Echogenic needle - Stimuplex Braun Nonechogenic needle
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Duration of block procedure		5- 15 minutes. Start of skin puncture till the final needle removal	Yes
Secondary	Time to onset of sensory blockade		0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.	Yes
Secondary	Time to onset of motor blockade		0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.	Yes
Secondary	Duration of sensory blockade		0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.	Yes
Secondary	Duration of motor blockade		0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.	Yes
Secondary	Block success rate of echogenic and Nonechogenic group.		Duration of surgery	No