Brachial Plexus BlockNCT02312453
Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block
A study testing Posterior approach in people with Brachial Plexus Block, run by University of Malaya.
Trial summary
Abstract Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brachial Plexus Block
- What is being tested?
- Posterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient's age between 18 and 80 years old,
- American Society of Anesthesiologists (ASA) physical status I - III,
- body mass index (BMI) between 20 and 35 kg/m2 and
- planned for surgery of the forearm, wrist, or hand.
Who cannot join
- patient's inability to give consent to the study,
- pre-existing neuropathy,
- infection at the site of puncture,
- coagulopathy, and
- allergy to amides local anaesthetics.
About this study
Official title: Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block - A Case Series
Abstract
Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach. A new posterior parasagittal in-plane ultrasound-guided infraclavicular approach was introduced to improve needle visibility. However no further follow up study was done.
Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012 to October 2013. After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively recruited. A cadaveric dissection was also performed. The endpoints of this study were the success rate, performance time, total anaesthesia related time, quality of anaesthesia and any incidence of complications.
Read the detailed description
Introduction Our study focus on the ultrasound guided infraclavicular brachial plexus block, which is a cord-level block of the brachial plexus for surgical procedures below mid-humerus. The brachial plexus at this level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach (lateral para-sagittal in-plane technique).1
A new ultrasound-guided posterior approach parasagittal in-plane infraclavicular block was introduced to improve needle visibility.2 However no further follow up study was done.
Therefore, we performed a case series of 18 patients with a cadaveric dissection, to assess the feasibility of this approach.
Methods After obtaining ethics committee approval from the Medical Ethics Committee, University Malaya Medical Center, Kuala Lumpur, Malaysia (Chairperson Professor Dr. Looi Lai Meng; IRB reference no. 949.14 dated 17 October 2012, amendment no.1038.76 dated 19 December 2013) and written informed consent, 18 patients undergoing surgery of the elbow, forearm, wrist, or hand were prospectively recruited based on the criteria below.
- Conditions
- Brachial Plexus Block
- Being tested
- Posterior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior approachProcedure or surgery
Also called posterior approach parasagittal in-plane
We adopted the technique as described by Hebbard et al.
| Study group | Role | What they receive |
|---|---|---|
| Posterior approach | Experimental | All patients were given a single shot ultrasound-guided posterior parasagittal in-plane approach infraclavicular brachial plexus block under aseptic technique. The blocks were performed using a 21G, 100 mm insulated short bevel needle (Stimuplex A, B Braun, Melsungen, Germany) without nerve stimulation. A 25-ml local anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] was administered. We used an ultrasound machine (Sonosite M-Turbo; Sonosite®, Bothell, WA, USA) with HFL38x/ 13-6 MHz linear transducer probe. Receives: Procedure: Posterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon)
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon
The adequacy of block was determined during assessment of motor and sensory blockade at predetermined intervals, every 5 minutes until 30 minutes; Please refer to the study detailed description.
Measured: participants will be followed up throughout operation duration
Secondary outcomes (3)
Performance parameters
Imaging time (defined as the time interval between contact of the ultrasound probe with the patient and the acquisition of a satisfactory sonoanatomy - a complete round short-axis view of the axillary artery) Needling time (defined as the time interval between the start of the needle insertion and the end of local anaesthetic injection through the needle) Performance time (defined as the sum of imaging and needling times).
Measured: participants will be followed up throughout the procedure
Safety aspects and potential complications as measured by incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity
The incidence of paraesthesia and vascular puncture was recorded if any. Horner's syndrome, dyspnoea and symptoms suggestive of local anaesthetic toxicity were routinely checked.
Measured: participants will be followed up throughout procedure, during operation and 1 week after the operation (via phone call)
adequacy of block for tourniquet application
The incidence of tourniquet pain
Measured: participants will be followed up throughout operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2013
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 Brachial Plexus BlockStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beh Zhi Yuen, University of Malaya
- Investigators
- Beh Zhi Yuen, MD, M.Anaes, Principal investigator, Department of Anaesthesiology, Faculty of Medicine, Univeristy of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312453
- Sponsor's protocol ID
- 1038.76
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
References 1. Chin KJ, Perlas A, Chan VW, et al. Needle visualization in ultrasound guided regional anaesthesia: challenges and solutions. Reg Anesth Pain Med 2008; 33:532-544 2. Hebbard P and Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia 2007; 62: 539 3. Levesque S, Dion N, Desgagne MC. Endpoint for successful, ultrasound-guided infraclavicular brachial plexus block. Can J Anaesth 2008; 55:308. 4. Tran DQH, Charghi R, Finlayson RJ. The 'Double Bubble' Sign for Successful Infraclavicular Brachial Plexus Blockade. Anesth Analg 2006; 103:1048-1049 5. Tran DQH, Bertini P, Zaouter C, et al. A Prospective, Randomized Comparison Between Single- and Double-Injection Ultrasound-Guided Infraclavicular Brachial Plexus Block. Reg Anesth Pain Med 2010; 35:16-21 6. Tran DQH, Munoz L, Zaouter C, et al. A prospective, randomized comparison between single- and double-injection ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med 2009; 34:420-424. 7. Tran DQH, Russo G, Munoz L, et al. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular and axillary brachial plexus blocks. Reg Anesth Pain Med 2009; 34:366-371
Beh ZY, Hasan MS, Lai HY, Kassim NM, Md Zin SR, Chin KF. Posterior parasagittal in-plane ultrasound-guided infraclavicular brachial plexus block-a case series. BMC Anesthesiol. 2015 Jul 21;15:105. doi: 10.1186/s12871-015-0090-0.
PubMed 26194896
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block - A Case Series
- ClinicalTrials.gov ID
- NCT02312453
- Acronym / sponsor ID
- 1038.76
- Conditions
- Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Dec 2014 (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.
Abstract
Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach. A new posterior parasagittal in-plane ultrasound-guided infraclavicular approach was introduced to improve needle visibility. However no further follow up study was done.
Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012 to October 2013. After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively recruited. A cadaveric dissection was also performed. The endpoints of this study were the success rate, performance time, total anaesthesia related time, quality of anaesthesia and any incidence of complications.
Detailed description
Introduction Our study focus on the ultrasound guided infraclavicular brachial plexus block, which is a cord-level block of the brachial plexus for surgical procedures below mid-humerus. The brachial plexus at this level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach (lateral para-sagittal in-plane technique).1
A new ultrasound-guided posterior approach parasagittal in-plane infraclavicular block was introduced to improve needle visibility.2 However no further follow up study was done.
Therefore, we performed a case series of 18 patients with a cadaveric dissection, to assess the feasibility of this approach.
Methods After obtaining ethics committee approval from the Medical Ethics Committee, University Malaya Medical Center, Kuala Lumpur, Malaysia (Chairperson Professor Dr. Looi Lai Meng; IRB reference no. 949.14 dated 17 October 2012, amendment no.1038.76 dated 19 December 2013) and written informed consent, 18 patients undergoing surgery of the elbow, forearm, wrist, or hand were prospectively recruited based on the criteria below.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posterior approach | Experimental | Procedure: Posterior approachAll patients were given a single shot ultrasound-guided posterior parasagittal in-plane approach infraclavicular brachial plexus block under aseptic technique. The blocks were performed using a 21G, 100 mm insulated short bevel needle (Stimuplex A, B Braun, Melsungen, Germany) without nerve stimulation. A 25-ml local anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] was administered. We used an ultrasound machine (Sonosite M-Turbo; Sonosite®, Bothell, WA, USA) with HFL38x/ 13-6 MHz linear transducer probe. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient's age between 18 and 80 years old,
- American Society of Anesthesiologists (ASA) physical status I - III,
- body mass index (BMI) between 20 and 35 kg/m2 and
- planned for surgery of the forearm, wrist, or hand.
Key exclusion criteria (5 listed)
- patient's inability to give consent to the study,
- pre-existing neuropathy,
- infection at the site of puncture,
- coagulopathy, and
- allergy to amides local anaesthetics.
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 |
|---|---|---|
| Posterior approachAlso: posterior approach parasagittal in-planeWe adopted the technique as described by Hebbard et al. | Procedure or surgery | Posterior approach |
Primary outcome
Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon)
Time frame: participants will be followed up throughout operation duration
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon The adequacy of block was determined during assessment of motor and sensory blockade at predetermined intervals, every 5 minutes until 30 minutes; Please refer to the study detailed description.
3 secondary outcomes
Performance parameters
Time frame: participants will be followed up throughout the procedure
Safety aspects and potential complications as measured by incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity
Time frame: participants will be followed up throughout procedure, during operation and 1 week after the operation (via phone call)
adequacy of block for tourniquet application
Time frame: participants will be followed up throughout operation
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 9 Dec 2014.
- BackgroundReferences 1. Chin KJ, Perlas A, Chan VW, et al. Needle visualization in ultrasound guided regional anaesthesia: challenges and solutions. Reg Anesth Pain Med 2008; 33:532-544 2. Hebbard P and Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia 2007; 62: 539 3. Levesque S, Dion N, Desgagne MC. Endpoint for successful, ultrasound-guided infraclavicular brachial plexus block. Can J Anaesth 2008; 55:308. 4. Tran DQH, Charghi R, Finlayson RJ. The 'Double Bubble' Sign for Successful Infraclavicular Brachial Plexus Blockade. Anesth Analg 2006; 103:1048-1049 5. Tran DQH, Bertini P, Zaouter C, et al. A Prospective, Randomized Comparison Between Single- and Double-Injection Ultrasound-Guided Infraclavicular Brachial Plexus Block. Reg Anesth Pain Med 2010; 35:16-21 6. Tran DQH, Munoz L, Zaouter C, et al. A prospective, randomized comparison between single- and double-injection ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med 2009; 34:420-424. 7. Tran DQH, Russo G, Munoz L, et al. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular and axillary brachial plexus blocks. Reg Anesth Pain Med 2009; 34:366-371
- Derived from this study: PubMed 26194896Beh ZY, Hasan MS, Lai HY, Kassim NM, Md Zin SR, Chin KF. Posterior parasagittal in-plane ultrasound-guided infraclavicular brachial plexus block-a case series. BMC Anesthesiol. 2015 Jul 21;15:105. doi: 10.1186/s12871-015-0090-0.
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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.
Beh Zhi Yuen, MD, M.Anaes principal investigator
Department of Anaesthesiology, Faculty of Medicine, Univeristy of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Posterior approach in people with Brachial Plexus Block, run by University of Malaya.
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 4 inclusion and 5 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 9 Dec 2014. 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. 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?
Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon) (time frame: participants will be followed up throughout operation duration). 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 NCT02312453, 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 9 Dec 2014.