Brachial Plexus BlockNCT02462408
Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
A study testing Posterior approach and Conventional approach in people with Brachial Plexus Block and Infraclavicular, run by University of Malaya.
Trial summary
The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brachial Plexus Block, Infraclavicular, Ultrasound Guided
- What is being tested?
- Posterior approach and Conventional approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 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
- American Society of Anesthesiologists (ASA) physical status I - III
- Body Mass Index (BMI) between 20 and 35 kg/m2
- Surgery of the forearm, wrist, or hand
Who cannot join
- Inability to give consent to the study
- Pre-existing neuropathy
- Infection at the site of puncture, skin ulcer
- Coagulopathy
- Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax
- Allergy to amides local anaesthetics
About this study
Official title: A Prospective, Randomized Comparison Between Lateral and Posterior Approach In Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation due to its steep angle of needle trajectory to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to improve needle visibility. This approach proved feasible from our case series hence the investigators would like to compare it with the conventional method in this study
Read the detailed description
This study compared the conventional lateral and posterior approach parasagittal in-plane ultrasound guided infraclavicular brachial plexus block for upper limb surgery. A cadaveric study was also performed to complement the findings.
After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre (IRB reference no. 949.14 dated 17 October 2012), 46 patients undergoing upper limb surgery were prospectively recruited and randomized. A cadaveric dissection was also performed.
DESIGN: Prospective randomized study
SETTING: Single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; November 2012 to October 2013
INTERVENTION: Ultrasound guided, lateral or posterior parasagittal in-plane infraclavicular brachial plexus blocks were performed on patients, depending on randomization. All blocks were performed using 21G x 4 inch Stimuplex A (B Braun Medical) without nerve stimulation plus SonoSite M-Turbo with HFL38x/ 13-6 MHz linear transducer probe. A 25-ml local anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] were injected to all patients. A total volume of normal saline 0.9% 25ml mixed with methylene blue (0.2ml) was used for cadaveric study.
- Conditions
- Brachial Plexus Block, Infraclavicular, Ultrasound Guided
- Being tested
- Posterior approach, Conventional approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior approachProcedure or surgery
The needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
Conventional approachProcedure or surgery
The needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
| Study group | Role | What they receive |
|---|---|---|
| Posterior approach | Experimental | The main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches. Receives: Procedure: Posterior approach |
| Conventional approach | Active comparator | The main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches. Receives: Procedure: Conventional 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 the operation duration; as stated each operation has variable duration of operation time, average operation time 2 to 4 hours
Secondary outcomes (3)
Performance parameters
This is a composite outcome measure. The anaesthesia assistant would record the time required to perform the procedure as follow below description:
(i)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), (ii) Needling time (defined as the time interval between the start of the needle insertion and the end of local anaesthetic injection through the needle), (iii) Performance time (defined as the sum of imaging and needling times). This timing definition had been published in other journals (please refer our references - 3)
Measured: participants will be followed up throughout the procedure (performing the blocks), average time for block perfomances 30 minutes
Safety aspects and potential complications; we measured by any incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity
This is a composite outcome measure. We measured safety aspects and potential complications by recording any incidence of paraesthesia and vascular puncture during block performances, any Horner's syndrome, dyspnoea and symptoms suggestive of local anaesthetic toxicity were routinely checked after the procedure and during surgery. To further enhance patient's safety, we would still follow up patient by phone call 1 week after the surgery
Measured: Participants would be followed up throughout procedure (average duration 30 minutes), during operation (average duration 2 to 4 hours) and 1 week after the operation (via phone call)
adequacy of block for tourniquet application
The incidence of tourniquet pain; this would describe whether the block technique covers for tourniquet pain
Measured: participants would be followed up throughout the operation duration whether they complained of pain at torniquet site during the operation duration; average duration of operation 2 - 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (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 (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 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, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462408
- Sponsor's protocol ID
- 949.14
- Status last verified
- Jun 2015
- First submitted
- 1 Apr 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. doi: 10.1016/j.rapm.2008.06.002.
PubMed 19258968Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.
PubMed 17448088Tran DQ, Charghi R, Finlayson RJ. The "double bubble" sign for successful infraclavicular brachial plexus blockade. Anesth Analg. 2006 Oct;103(4):1048-9. doi: 10.1213/01.ane.0000239077.49794.a5. No abstract available.
PubMed 17000840Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
PubMed 20048654
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison Between Lateral and Posterior Approach In Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT02462408
- Acronym / sponsor ID
- 949.14
- Conditions
- Brachial Plexus Block, Infraclavicular, Ultrasound Guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 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
- 4 Jun 2015 (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 lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation due to its steep angle of needle trajectory to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to improve needle visibility. This approach proved feasible from our case series hence the investigators would like to compare it with the conventional method in this study
Detailed description
This study compared the conventional lateral and posterior approach parasagittal in-plane ultrasound guided infraclavicular brachial plexus block for upper limb surgery. A cadaveric study was also performed to complement the findings.
After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre (IRB reference no. 949.14 dated 17 October 2012), 46 patients undergoing upper limb surgery were prospectively recruited and randomized. A cadaveric dissection was also performed.
DESIGN: Prospective randomized study
SETTING: Single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; November 2012 to October 2013
INTERVENTION: Ultrasound guided, lateral or posterior parasagittal in-plane infraclavicular brachial plexus blocks were performed on patients, depending on randomization. All blocks were performed using 21G x 4 inch Stimuplex A (B Braun Medical) without nerve stimulation plus SonoSite M-Turbo with HFL38x/ 13-6 MHz linear transducer probe. A 25-ml local anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] were injected to all patients. A total volume of normal saline 0.9% 25ml mixed with methylene blue (0.2ml) was used for cadaveric study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior approach | Experimental | Procedure: Posterior approachThe main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches. |
| Conventional approach | Active comparator | Procedure: Conventional approachThe main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I - III
- Body Mass Index (BMI) between 20 and 35 kg/m2
- Surgery of the forearm, wrist, or hand
Key exclusion criteria (6 listed)
- Inability to give consent to the study
- Pre-existing neuropathy
- Infection at the site of puncture, skin ulcer
- Coagulopathy
- Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax
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 approachThe needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique. | Procedure or surgery | Posterior approach |
| Conventional approachThe needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique. | Procedure or surgery | Conventional 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 the operation duration; as stated each operation has variable duration of operation time, average operation time 2 to 4 hours
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 (performing the blocks), average time for block perfomances 30 minutes
Safety aspects and potential complications; we measured by any incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity
Time frame: Participants would be followed up throughout procedure (average duration 30 minutes), during operation (average duration 2 to 4 hours) and 1 week after the operation (via phone call)
adequacy of block for tourniquet application
Time frame: participants would be followed up throughout the operation duration whether they complained of pain at torniquet site during the operation duration; average duration of operation 2 - 4 hours
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 4 Jun 2015.
- Background: PubMed 19258968Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. doi: 10.1016/j.rapm.2008.06.002.
- Background: PubMed 17448088Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.
- Background: PubMed 17000840Tran DQ, Charghi R, Finlayson RJ. The "double bubble" sign for successful infraclavicular brachial plexus blockade. Anesth Analg. 2006 Oct;103(4):1048-9. doi: 10.1213/01.ane.0000239077.49794.a5. No abstract available.
- Background: PubMed 20048654Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
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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
University of Malaya
Questions about this trial
What is this clinical trial studying?
A study testing Posterior approach and Conventional approach in people with Brachial Plexus Block and Infraclavicular, 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 3 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 4 Jun 2015. 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 the operation duration; as stated each operation has variable duration of operation time, average operation time 2 to 4 hours). 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 NCT02462408, which also lists 4 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 4 Jun 2015.