Needle TrackNCT02799576
A Curved Block Needle for the Infraclavicular Brachial Plexus Block
A study testing Curved needle in people with Needle Track, run by Suez Canal University at 1 site in Egypt.
Trial summary
The investigators hypothesized that using the curved needle could facilitate the block placement and provide short procedure time. Aim of the work: The investigators will compare namely straight and curved block needle with in-plane needle insertion techniques for the infraclavicular brachial plexus nerve block (ICNB)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Needle Track
- What is being tested?
- Curved needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Oct 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 60 year old both sex, able to provide informed consent to participate, enrolled in elective surgery distal to the elbow, single procedure.
Who cannot join
- Unable to consent to participate, known to have lidocaine or bupivacaine allergy, more than one procedure will be performed at the same setting, patients with local infections,neuropathies, coagulopathies,and history of chronic analgesic therapy, Obesity (body mass index ≥ 30 kg/m2),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Curved Block Needle for the Infraclavicular Brachial Plexus Block in Patients Undergoing Surgery Distal to the Elbow
The investigators hypothesized that using the curved needle could facilitate the block placement and provide short procedure time. Aim of the work: The investigators will compare namely straight and curved block needle with in-plane needle insertion techniques for the infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.
Read the detailed description
Sometimes, there is a limited block needle access at the inferior edge of the clavicle while performing in- plane infraclavicular parasagittal blockade. This might present a challenge in manipulating and visualizing the block needle in easy way along its entire trajectory during the blockade. The curved block needle might have its positive impact on the capacity to control the block needle advancement relative to the target nerve.
70 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I- II, scheduled for elective surgery distal to the elbow will be enrolled in a prospective, comparative, randomized clinical study.
Patients will be randomly assigned into two groups: C (n = 35), in whom US-guided single injection ICNB will be performed using a curved line needle; and S (n = 35), in whom US-guided ICNB will be performed using a straight line needle. All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.
The ultrasound guided Infraclavicular brachial plexus block will be performed in the block room using a linear-array US probe (8-13 MHz). The ultrasound probe will be placed just below the lower edge of the clavicle and medial to the coracoid process (parasagittal orientation), with adjustment of depth, frequency and gain to spot the best view of the transverse axillary artery and its surrounding cords (short-axis view).
After sterile skin preparation with chlorhexidine solution, local infiltration with 2 ml of lidocaine (10 mg/ml) will be made at the cephalad aspect of the ultrasound probe. A 10-cm, short-bevel block (straight or curved) needle will be attached to the nerve stimulator delivering a current of 1.2 mA ( milliampere) at a frequency of 2 Hz (Hertz), will be inserted in-plane just inferior to the clavicle.
After eliciting the posterior cord motor response (finger or wrist extension) with a current intensity of ≤ 0.5 mA, correct needle-tip position will be confirmed by test injections with 1 ml of 5 % dextrose solution. Then, thirty milliliters of local anesthetic mixture (lidocaine 10 mg/ml and bupivacaine 2.5 mg/ml) will be incrementally injected after careful aspiration. The goal is to ensuring a U-shaped distribution of anaesthetic solution with anterior displacement of the axillary artery.
- Conditions
- Needle Track
- Being tested
- Curved needle
- Keywords
- Ultrasound, Regional blockade, Infraclavicular brachial plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curved needleDevice
In this arm, the curved block needle will be used for regional blockade
| Study group | Role | What they receive |
|---|---|---|
| Curved needle | Experimental | This will utilize the curved block needle of performance of regional block Receives: Device: Curved needle |
| Traditional needle | No intervention | This will utilize the traditional block needle of performance of regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance time
The time to perform the Infraclavicular brachial nerve block. Performance time is defined as the sum of recognition time and local anesthetics injection time. Recognition time is defined as the time interval in seconds (s) from needle insertion to achievement of proper motor response. Local anesthetics injection time is defined as the time interval in seconds (s) between the achievement of motor response and the end of local anesthetics injection through the block needle
Measured: 12 min
Secondary outcomes (5)
Number of needle attempts to elicit proper motor response
New attempt will be defined as needle reinsertions through separate skin puncture.
Measured: 12 min
Number of needle redirections to elicit proper motor response
Needle redirection will be defined as draw back and redirects the needle if no proper nerve response could be elicited.
Measured: 12 min
The Infraclavicular brachial nerve block success rate
The Infraclavicular brachial nerve block success will be assessed according to the adequacy of surgical anesthesia and is defined as complete loss of pinprick sensation within 30 min of anesthetic administration and if no supplementation (sedative or analgesic) is required during surgery. Partial block is defined as inadequate sensory blockade after 30 min of anesthetic administration. The supplementation (IV analgesic, rescue blocks or local infiltration) is required to complete the proposed surgery. Failed block is considered if general anesthesia is required to complete the proposed surgery.
Measured: 30 min after local anesthetics administration
Patient satisfaction
All patients will be asked to rate their discomfort during the block placement and tourniquet pain using the Verbal Rating Scale (VRS: 0 = no discomfort, 10 = the worst discomfort).
Measured: during surgical procedures
Anesthesiologist satisfaction
Level of anesthesiologist satisfaction for using different block needles will be evaluated using VRS (0, no satisfaction; 10, maximum satisfaction).
Measured: 12 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Needle TrackStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek F.Tammam, Suez Canal University
- Investigators
- Tarek F. Tammam, Prof., Study director, Suez Canal university,Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799576
- Sponsor's protocol ID
- TFTammam
- Other IDs
- Ghada A. K
- Status last verified
- Oct 2017
- First submitted
- 6 Jun 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tammam TF, Kamhawy GA. Use of a curved needle to facilitate lateral sagittal infraclavicular block performance: a randomized clinical trial. J Anesth. 2019 Oct;33(5):604-611. doi: 10.1007/s00540-019-02674-w. Epub 2019 Aug 29.
PubMed 31468177
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Curved Block Needle for the Infraclavicular Brachial Plexus Block in Patients Undergoing Surgery Distal to the Elbow
- ClinicalTrials.gov ID
- NCT02799576
- Acronym / sponsor ID
- TFTammam
- Conditions
- Needle Track
- Keywords
- Ultrasound, Regional blockade, Infraclavicular brachial plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 15 Jun 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.
The investigators hypothesized that using the curved needle could facilitate the block placement and provide short procedure time. Aim of the work: The investigators will compare namely straight and curved block needle with in-plane needle insertion techniques for the infraclavicular brachial plexus nerve block (ICNB) regarding the block performance time.
Detailed description
Sometimes, there is a limited block needle access at the inferior edge of the clavicle while performing in- plane infraclavicular parasagittal blockade. This might present a challenge in manipulating and visualizing the block needle in easy way along its entire trajectory during the blockade. The curved block needle might have its positive impact on the capacity to control the block needle advancement relative to the target nerve.
70 patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I- II, scheduled for elective surgery distal to the elbow will be enrolled in a prospective, comparative, randomized clinical study.
Patients will be randomly assigned into two groups: C (n = 35), in whom US-guided single injection ICNB will be performed using a curved line needle; and S (n = 35), in whom US-guided ICNB will be performed using a straight line needle. All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure, and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.
The ultrasound guided Infraclavicular brachial plexus block will be performed in the block room using a linear-array US probe (8-13 MHz). The ultrasound probe will be placed just below the lower edge of the clavicle and medial to the coracoid process (parasagittal orientation), with adjustment of depth, frequency and gain to spot the best view of the transverse axillary artery and its surrounding cords (short-axis view).
After sterile skin preparation with chlorhexidine solution, local infiltration with 2 ml of lidocaine (10 mg/ml) will be made at the cephalad aspect of the ultrasound probe. A 10-cm, short-bevel block (straight or curved) needle will be attached to the nerve stimulator delivering a current of 1.2 mA ( milliampere) at a frequency of 2 Hz (Hertz), will be inserted in-plane just inferior to the clavicle.
After eliciting the posterior cord motor response (finger or wrist extension) with a current intensity of ≤ 0.5 mA, correct needle-tip position will be confirmed by test injections with 1 ml of 5 % dextrose solution. Then, thirty milliliters of local anesthetic mixture (lidocaine 10 mg/ml and bupivacaine 2.5 mg/ml) will be incrementally injected after careful aspiration. The goal is to ensuring a U-shaped distribution of anaesthetic solution with anterior displacement of the axillary artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curved needle | Experimental | Device: Curved needleThis will utilize the curved block needle of performance of regional block |
| Traditional needle | No intervention | –This will utilize the traditional block needle of performance of regional block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 - 60 year old both sex, able to provide informed consent to participate, enrolled in elective surgery distal to the elbow, single procedure.
Key exclusion criteria (1 listed)
- Unable to consent to participate, known to have lidocaine or bupivacaine allergy, more than one procedure will be performed at the same setting, patients with local infections,neuropathies, coagulopathies,and history of chronic analgesic therapy, Obesity (body mass index ≥ 30 kg/m2),
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 |
|---|---|---|
| Curved needleIn this arm, the curved block needle will be used for regional blockade | Device | Curved needle |
Primary outcome
Performance time
Time frame: 12 min
The time to perform the Infraclavicular brachial nerve block. Performance time is defined as the sum of recognition time and local anesthetics injection time. Recognition time is defined as the time interval in seconds (s) from needle insertion to achievement of proper motor response. Local anesthetics injection time is defined as the time interval in seconds (s) between the achievement of motor response and the end of local anesthetics injection through the block needle
5 secondary outcomes
Number of needle attempts to elicit proper motor response
Time frame: 12 min
Number of needle redirections to elicit proper motor response
Time frame: 12 min
The Infraclavicular brachial nerve block success rate
Time frame: 30 min after local anesthetics administration
Patient satisfaction
Time frame: during surgical procedures
Anesthesiologist satisfaction
Time frame: 12 min
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 19 Oct 2017.
- Derived from this study: PubMed 31468177Tammam TF, Kamhawy GA. Use of a curved needle to facilitate lateral sagittal infraclavicular block performance: a randomized clinical trial. J Anesth. 2019 Oct;33(5):604-611. doi: 10.1007/s00540-019-02674-w. Epub 2019 Aug 29.
- Individual participant dataSharing planned: Undecided
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.
Tarek F. Tammam, Prof. study director
Suez Canal university,Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curved needle in people with Needle Track, run by Suez Canal University at 1 site in Egypt.
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 1 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Performance time (time frame: 12 min). 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 NCT02799576, which also lists 1 linked publication.
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 19 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.