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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Show all 10Show fewer
  • 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)

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 groups in NCT03207035
Study groupRoleWhat they receive
20 ml of lidocaine 2% with epinephrineActive comparatorPatients 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 epinephrineExperimentalPatients 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.

  1. Onset of Axillary Block

    Time taken for onset of sensory and motor axillary brachial plexus block

    Measured: 1 day

Secondary outcomes (7)
  1. Duration of Sensory and Motor Block

    Total duration of sensory and motor block of ultrasound guided axillary brachial plexus block

    Measured: 1 day

  2. Block Performance Data- Imaging Time

    Time taken to obtain appropriate ultrasound image to perform the axillary plexus block

    Measured: 1 Hour

  3. Needling Time

    Time taken to perform the block in minutes

    Measured: 1Hour

  4. Performance Time

    Sum of imaging and performance time

    Measured: 1 Hour

  5. No of Needle Pass

    Number of needle passes while performing the axillary block

    Measured: 1 Hour

  6. Vascular Puncture

    Incidence of vascular puncture during the performance of block.

    Measured: 1 Hour

  7. 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.

  1. First posted2 Jul 2017
  2. Study start15 Oct 2014
  3. Primary completion14 Mar 2016
  4. Study completion14 Mar 2016

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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