Brachial Plexus BlockadeNCT03207035
Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block
A study testing Axillary brachial plexus block in people with Brachial Plexus Blockade, run by Cork University Hospital.
Trial summary
We propose to compare the effects of local anaesthetic dilution on the characteristics of the ultrasound guided axillary brachial plexus block. Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brachial Plexus Blockade
- What is being tested?
- Axillary brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2014to 14 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- Patients aged >18 years undergoing elective upper limb (forearm or hand) surgical procedures.
Who cannot join
- Contraindications to regional anaesthesia
- Hypersensitivity to amide local anaesthetics.
- Chronic pain
- Language barrier
- Neuromuscular disorders or peripheral neuropathy
- Body mass index > 35
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- History of hepatic and renal insufficiency
- Pregnancy
- Cognitive or psychiatric disorder
- Cardiac conduction abnormality.
About this study
We propose to compare the effects of local anaesthetic dilution on the characteristics of the ultrasound guided axillary brachial plexus block.
Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with epinephrine for elective upper limb surgical procedures.
Read the detailed description
To compare the effects of local anaesthetic 20 mL lidocaine 1% with epinephrine vs 40 mL lidocaine 1% with epinephrine on the onset of sensory and motor block following ultrasound guided axillary brachial plexus block.
Methods:
It is a prospective, randomized, observer blinded study. With institutional ethical approval and having obtained written informed consent from each, 20 patients will be studied.
Randomisation and blinding:
Using a computer generated and sealed envelope technique, 20 patients will be randomly allocated in to one of two groups.
Group 1: patients will receive 20 ml of lidocaine 2% with epinephrine. Group 2: patients will receive 40 ml of lidocaine 1% with epinephrine.
Sample size and statistical analysis:
In the absence of data from previous study using 20 ml of lidocaine with epinephrine for ultrasound guided axillary brachial plexus block. Sample size was calculated based on from our pilot study of 12 patients. We found mean onset of block of 11.25 (SD, 2.3) mins. The minimum sample size required to have an 80% probability of detecting a 30% decrease in onset time (level of significance 0.05) will be 7 patients per group using an unpaired student's t test. Recruited 10 per group
Anaesthetic procedure:
Having established intravenous access, standard anaesthetic monitoring will be applied. Premedication with midazolam will be administered as clinically indicated (to a maximum of 3 mg). The operative arm will be abducted and externally rotated with elbow flexed at 90 degrees. Under strict aseptic condition, ultrasound guided axillary brachial plexus block will be performed. Having identified musculocutaneous, median, radial and ulnar nerves, a 50mm 24-gauge stimuplex short bevel insulated needle will be used with in-plane approach to block each nerve with either 5 (Group 1) or 10 ml (Group 2). All blocks will be performed by operator experienced in the ultrasound peripheral nerve blocks.
Block assessment:
When the block procedure has been completed, a blinded observer will assess the onset of sensory and motor block in the innervation of each nerve every 2.5 mins, until surgical anaesthesia is achieved or 30 mins have elapsed (Table 1). Surgical anaesthesia will be defined as a motor score ≤2, with absent sensation to cold and pinprick. Each nerve distribution will be individually assessed. Onset time will be measured from conclusion of the block (t=0) to attainment of surgical anaesthesia. Block will be deemed failure if surgical anaesthesia has not been achieved at 30 mins in one or more of the four nerve distribution. In case of failure, an additional rescue block or conversion to general anaesthesia will be performed. DATA from these patients will be analysed separately.
Intraoperative period:
All patients will receive 1 g of paracetamol and diclofenac 75 mg iv during surgery. In case of patients discomfort sedation and rescue analgesia in the form of fentanyl 25 micrograms aliquots IV will be administered to a maximum of 100 micrograms.
Postoperative period:
Upon arrival to recovery room, sensory and motor function will be assessed every 15 mins by a blinded observer.15 Assessment will be performed for each nerve separately. Block regression is defined as a return of sensation to cold and pinprick with motor power score ≥3 in any nerve region. Time to first request for postoperative analgesia and total opioid consumption for 24 hrs will be noted. Postoperative analgesia will be prescribed as paracetamol 1 g 6 hourly and diclofenac sodium 75 mg 12 hourly. Oxycodone 5-10 mg orally 4-6 hourly will be administered as rescue analgesia.
Primary Outcome: onset of block.
Secondary Outcomes: Duration of sensory and motor block and block performance data (Imaging time, Needling time, Performance time, No of needle pass, Vascular puncture and parasthesia)
- Conditions
- Brachial Plexus Blockade
- Being tested
- Axillary brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary brachial plexus blockProcedure or surgery
Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 20 ml of lidocaine 2% with epinephrine | Active comparator | Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine. Receives: Procedure: Axillary brachial plexus block |
| 40 ml 0f lidocaine 1% with epinephrine | Experimental | Patients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml) Receives: Procedure: Axillary brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Axillary Block
Time taken for onset of sensory and motor axillary brachial plexus block
Measured: 1 day
Secondary outcomes (7)
Duration of Sensory and Motor Block
Total duration of sensory and motor block of ultrasound guided axillary brachial plexus block
Measured: 1 day
Block Performance Data- Imaging Time
Time taken to obtain appropriate ultrasound image to perform the axillary plexus block
Measured: 1 Hour
Needling Time
Time taken to perform the block in minutes
Measured: 1Hour
Performance Time
Sum of imaging and performance time
Measured: 1 Hour
No of Needle Pass
Number of needle passes while performing the axillary block
Measured: 1 Hour
Vascular Puncture
Incidence of vascular puncture during the performance of block.
Measured: 1 Hour
Parasthesia
Incidence of parasthesia during the performance of axillary block
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start15 Oct 2014
- Primary completion14 Mar 2016
- Study completion14 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brachial Plexus BlockadeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anil Ranganath, Cork University Hospital
- Investigators
- Anil Ranganath, FCAI, Principal investigator, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207035
- Sponsor's protocol ID
- ECM 4 (mm)
- Status last verified
- Oct 2021
- First submitted
- 7 May 2017
- Last updated
- 18 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03207035
- Acronym / sponsor ID
- ECM 4 (mm)
- Conditions
- Brachial Plexus Blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 14 Mar 2016 (actual)
- Study completion
- 14 Mar 2016 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 18 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to compare the effects of local anaesthetic dilution on the characteristics of the ultrasound guided axillary brachial plexus block.
Administration of 40ml lidocaine 1% with epinephrine will shorten the onset time of ultrasound guided axillary brachial plexus block when compared to 20 mL lidocaine 2% with epinephrine for elective upper limb surgical procedures.
Detailed description
To compare the effects of local anaesthetic 20 mL lidocaine 1% with epinephrine vs 40 mL lidocaine 1% with epinephrine on the onset of sensory and motor block following ultrasound guided axillary brachial plexus block.
Methods:
It is a prospective, randomized, observer blinded study. With institutional ethical approval and having obtained written informed consent from each, 20 patients will be studied.
Randomisation and blinding:
Using a computer generated and sealed envelope technique, 20 patients will be randomly allocated in to one of two groups.
Group 1: patients will receive 20 ml of lidocaine 2% with epinephrine. Group 2: patients will receive 40 ml of lidocaine 1% with epinephrine.
Sample size and statistical analysis:
In the absence of data from previous study using 20 ml of lidocaine with epinephrine for ultrasound guided axillary brachial plexus block. Sample size was calculated based on from our pilot study of 12 patients. We found mean onset of block of 11.25 (SD, 2.3) mins. The minimum sample size required to have an 80% probability of detecting a 30% decrease in onset time (level of significance 0.05) will be 7 patients per group using an unpaired student's t test. Recruited 10 per group
Anaesthetic procedure:
Having established intravenous access, standard anaesthetic monitoring will be applied. Premedication with midazolam will be administered as clinically indicated (to a maximum of 3 mg). The operative arm will be abducted and externally rotated with elbow flexed at 90 degrees. Under strict aseptic condition, ultrasound guided axillary brachial plexus block will be performed. Having identified musculocutaneous, median, radial and ulnar nerves, a 50mm 24-gauge stimuplex short bevel insulated needle will be used with in-plane approach to block each nerve with either 5 (Group 1) or 10 ml (Group 2). All blocks will be performed by operator experienced in the ultrasound peripheral nerve blocks.
Block assessment:
When the block procedure has been completed, a blinded observer will assess the onset of sensory and motor block in the innervation of each nerve every 2.5 mins, until surgical anaesthesia is achieved or 30 mins have elapsed (Table 1). Surgical anaesthesia will be defined as a motor score ≤2, with absent sensation to cold and pinprick. Each nerve distribution will be individually assessed. Onset time will be measured from conclusion of the block (t=0) to attainment of surgical anaesthesia. Block will be deemed failure if surgical anaesthesia has not been achieved at 30 mins in one or more of the four nerve distribution. In case of failure, an additional rescue block or conversion to general anaesthesia will be performed. DATA from these patients will be analysed separately.
Intraoperative period:
All patients will receive 1 g of paracetamol and diclofenac 75 mg iv during surgery. In case of patients discomfort sedation and rescue analgesia in the form of fentanyl 25 micrograms aliquots IV will be administered to a maximum of 100 micrograms.
Postoperative period:
Upon arrival to recovery room, sensory and motor function will be assessed every 15 mins by a blinded observer.15 Assessment will be performed for each nerve separately. Block regression is defined as a return of sensation to cold and pinprick with motor power score ≥3 in any nerve region. Time to first request for postoperative analgesia and total opioid consumption for 24 hrs will be noted. Postoperative analgesia will be prescribed as paracetamol 1 g 6 hourly and diclofenac sodium 75 mg 12 hourly. Oxycodone 5-10 mg orally 4-6 hourly will be administered as rescue analgesia.
Primary Outcome: onset of block.
Secondary Outcomes: Duration of sensory and motor block and block performance data (Imaging time, Needling time, Performance time, No of needle pass, Vascular puncture and parasthesia)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 ml of lidocaine 2% with epinephrine | Active comparator | Procedure: Axillary brachial plexus blockPatients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine. |
| 40 ml 0f lidocaine 1% with epinephrine | Experimental | Procedure: Axillary brachial plexus blockPatients will receive axillary brachial plexus block with 20 ml of lidocaine 1% with epinephrine diluted with 20 ml of nacl 0.9% ( total 40 ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3
- Patients aged >18 years undergoing elective upper limb (forearm or hand) surgical procedures.
Key exclusion criteria (10 listed)
- Contraindications to regional anaesthesia
- Hypersensitivity to amide local anaesthetics.
- Chronic pain
- Language barrier
- Neuromuscular disorders or peripheral neuropathy
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 |
|---|---|---|
| Axillary brachial plexus blockUltrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine | Procedure or surgery | 20 ml of lidocaine 2% with epinephrine, 40 ml 0f lidocaine 1% with epinephrine |
Primary outcome
Onset of Axillary Block
Time frame: 1 day
Time taken for onset of sensory and motor axillary brachial plexus block
7 secondary outcomes
Duration of Sensory and Motor Block
Time frame: 1 day
Block Performance Data- Imaging Time
Time frame: 1 Hour
Needling Time
Time frame: 1Hour
Performance Time
Time frame: 1 Hour
No of Needle Pass
Time frame: 1 Hour
Vascular Puncture
Time frame: 1 Hour
Parasthesia
Time frame: 1 Hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anil Ranganath, FCAI principal investigator
Cork University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Axillary brachial plexus block in people with Brachial Plexus Blockade, run by Cork University Hospital.
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 2 inclusion and 10 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 18 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Onset of Axillary Block (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.