Upper Extremity Injury TraumaNCT02862041
Effectiveness of Echogenic and Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block
A study testing Echogenic needle - Pajunk sonoplex echogenic needle and Non Echogenic needle - Stimuplex Braun Nonechogenic needle in people with Upper Extremity Injury Trauma, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Injury Trauma
- What is being tested?
- Echogenic needle - Pajunk sonoplex echogenic needle and Non Echogenic needle - Stimuplex Braun Nonechogenic needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years, both male and female scheduled for upper extremity surgery
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Echogenic needle - Pajunk sonoplex echogenic needle, Non Echogenic needle - Stimuplex Braun Nonechogenic needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echogenic needle - Pajunk sonoplex echogenic needleDevice
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
Non Echogenic needle - Stimuplex Braun Nonechogenic needleDevice
Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
| Study group | Role | What they receive |
|---|---|---|
| Group Echogenic | Active comparator | Ultrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle Receives: Device: Echogenic needle - Pajunk sonoplex echogenic needle |
| Group Nonechogenic | Placebo comparator | Non echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle Receives: Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of Block procedure
Secondary outcomes (6)
Duration of block procedure
Measured: 5- 15 minutes. Start of skin puncture till the final needle removal
Time to onset of sensory blockade
Measured: 0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.
Time to onset of motor blockade
Measured: 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
Duration of sensory blockade
Measured: 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
Duration of motor blockade
Measured: 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
Block success rate of echogenic and Nonechogenic group.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity Injury TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinoth Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Vinoth kumar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862041
- Sponsor's protocol ID
- NK/1609/MD/10109-10
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 21425515Duger 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.
PubMed 23869186
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study
- ClinicalTrials.gov ID
- NCT02862041
- Acronym / sponsor ID
- NK/1609/MD/10109-10
- Conditions
- Upper Extremity Injury Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Echogenic | Active comparator | Device: Echogenic needle - Pajunk sonoplex echogenic needleUltrasound guided infraclavicular brachial plexus block with Pajunk sonoplex echogenic needle |
| Group Nonechogenic | Placebo comparator | Device: Non Echogenic needle - Stimuplex Braun Nonechogenic needleNon echogenic needle group, ultrasound guided infraclavicular brachial plexus block with Stimuplex Braun non echogenic needle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-60 years, both male and female scheduled for upper extremity surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echogenic needle - Pajunk sonoplex echogenic needleUltrasound guided infraclavicular brachial plexus block for upper extremity surgeries | Device | Group Echogenic |
| Non Echogenic needle - Stimuplex Braun Nonechogenic needleUltrasound guided infraclavicular brachial plexus block for upper extremity surgeries | Device | Group Nonechogenic |
Primary outcome
Needle tip and shaft visibility
Time frame: Duration of Block procedure
Percentage Needle Tip \& shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time*100
6 secondary outcomes
Duration of block procedure
Time frame: 5- 15 minutes. Start of skin puncture till the final needle removal
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.
Time to onset of motor blockade
Time frame: 0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.
Duration of sensory blockade
Time frame: 0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.
Duration of motor blockade
Time frame: 0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.
Block success rate of echogenic and Nonechogenic group.
Time frame: Duration of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Background: PubMed 21425515Hebard 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.
- Background: PubMed 23869186Duger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinoth kumar, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
A study testing Echogenic needle - Pajunk sonoplex echogenic needle and Non Echogenic needle - Stimuplex Braun Nonechogenic needle in people with Upper Extremity Injury Trauma, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle tip and shaft visibility (time frame: Duration of Block procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.