Clinical trial NCT02862041: 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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Injury Trauma
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Needle tip and shaft visibility
timeFrame: Duration of Block procedure
Secondary outcomes:
measure: Duration of block procedure
timeFrame: 5- 15 minutes. Start of skin puncture till the final needle removal
measure: Time to onset of sensory blockade
timeFrame: 0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.
measure: Time to onset of motor blockade
timeFrame: 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
measure: Duration of sensory blockade
timeFrame: 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
measure: Duration of motor blockade
timeFrame: 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
measure: Block success rate of echogenic and Nonechogenic group.
timeFrame: Duration of surgery
Other outcomes:
Locations:
Study officials:
affiliation: PGIMER
name: Vinoth kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.