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

NCT ID: NCT02862041

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Upper Extremity Injury Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Group Echogenic

Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle

Group Type: ACTIVE_COMPARATOR

Echogenic needle - Pajunk sonoplex echogenic needle

Intervention Type: DEVICE

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Group Nonechogenic

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

Group Type: PLACEBO_COMPARATOR

Non Echogenic needle - Stimuplex Braun Nonechogenic needle

Intervention Type: DEVICE

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Interventions

Echogenic needle - Pajunk sonoplex echogenic needle

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Intervention Type: DEVICE

Non Echogenic needle - Stimuplex Braun Nonechogenic needle

Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Vinoth Kumar

Junior resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinoth kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

References

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.

Reference Type: BACKGROUND

PMID: 21425515 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23869186 (View on PubMed)

Other Identifiers

NK/1609/MD/10109-10

Identifier Type: -

Identifier Source: org_study_id