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Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block

Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03207035
Enrollment
20
Registered
2017-07-02
Start date
2014-10-15
Completion date
2016-03-14
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Blockade

Brief 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 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)

Interventions

Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine

Sponsors

Cork University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA 1-3 * Patients aged \>18 years undergoing elective upper limb (forearm or hand) surgical procedures.

Exclusion criteria

* Contraindications to regional anaesthesia * Hypersensitivity to amide local anaesthetics. * Chronic pain * Language barrier * Neuromuscular disorders or peripheral neuropathy * Body mass index \> 35 * History of hepatic and renal insufficiency * Pregnancy * Cognitive or psychiatric disorder * Cardiac conduction abnormality.

Design outcomes

Primary

MeasureTime frameDescription
Onset of Axillary Block1 dayTime taken for onset of sensory and motor axillary brachial plexus block

Secondary

MeasureTime frameDescription
Block Performance Data- Imaging Time1 HourTime taken to obtain appropriate ultrasound image to perform the axillary plexus block
Needling Time1HourTime taken to perform the block in minutes
Performance Time1 HourSum of imaging and performance time
Duration of Sensory and Motor Block1 dayTotal duration of sensory and motor block of ultrasound guided axillary brachial plexus block
Vascular Puncture1 HourIncidence of vascular puncture during the performance of block.
Parasthesia1 HourIncidence of parasthesia during the performance of axillary block
No of Needle Pass1 HourNumber of needle passes while performing the axillary block

Participant flow

Recruitment details

Enrollment Assessed for eligibility: n=45 Excluded : n= 25 * Not meeting inclusion criteria: n = 5 * Declined to participate: n = 20 Randomized: n= 20

Participants by arm

ArmCount
20 ml of Lidocaine 2% With Epinephrine
Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine. Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine
10
40 ml 0f Lidocaine 1% With Epinephrine
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) Axillary brachial plexus block: Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine
10
Total20

Baseline characteristics

Characteristic20 ml of Lidocaine 2% With Epinephrine40 ml 0f Lidocaine 1% With EpinephrineTotal
Age, Continuous46.8 years
STANDARD_DEVIATION 18.2
48 years
STANDARD_DEVIATION 15.7
47.4 years
STANDARD_DEVIATION 16.6
Region of Enrollment
Ireland
10 Participants10 Participants20 Participants
Sex: Female, Male
Female
3 Participants2 Participants5 Participants
Sex: Female, Male
Male
7 Participants8 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

Primary

Onset of Axillary Block

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

Time frame: 1 day

ArmMeasureValue (MEDIAN)
20 ml of Lidocaine 2% With EpinephrineOnset of Axillary Block8.75 minutes
40 ml 0f Lidocaine 1% With EpinephrineOnset of Axillary Block6.25 minutes
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary

Block Performance Data- Imaging Time

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

Time frame: 1 Hour

ArmMeasureValue (MEAN)Dispersion
20 ml of Lidocaine 2% With EpinephrineBlock Performance Data- Imaging Time2.5 minutesStandard Deviation 0.5
40 ml 0f Lidocaine 1% With EpinephrineBlock Performance Data- Imaging Time2.4 minutesStandard Deviation 0.6
p-value: 0.7t-test, 2 sided
Secondary

Duration of Sensory and Motor Block

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

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
20 ml of Lidocaine 2% With EpinephrineDuration of Sensory and Motor Block165.1 minutesStandard Deviation 5.9
40 ml 0f Lidocaine 1% With EpinephrineDuration of Sensory and Motor Block150.9 minutesStandard Deviation 17.2
p-value: 0.02t-test, 2 sided
Secondary

Needling Time

Time taken to perform the block in minutes

Time frame: 1Hour

ArmMeasureValue (MEAN)Dispersion
20 ml of Lidocaine 2% With EpinephrineNeedling Time8.5 minutesStandard Deviation 1.2
40 ml 0f Lidocaine 1% With EpinephrineNeedling Time6.7 minutesStandard Deviation 0.9
p-value: 0.002t-test, 2 sided
Secondary

No of Needle Pass

Number of needle passes while performing the axillary block

Time frame: 1 Hour

ArmMeasureValue (MEAN)Dispersion
20 ml of Lidocaine 2% With EpinephrineNo of Needle Pass10.5 Needle passesStandard Deviation 2.3
40 ml 0f Lidocaine 1% With EpinephrineNo of Needle Pass9.1 Needle passesStandard Deviation 0.5
p-value: 0.001t-test, 2 sided
Secondary

Parasthesia

Incidence of parasthesia during the performance of axillary block

Time frame: 1 Hour

ArmMeasureValue (NUMBER)
20 ml of Lidocaine 2% With EpinephrineParasthesia4 Parasthesia events
40 ml 0f Lidocaine 1% With EpinephrineParasthesia2 Parasthesia events
p-value: 0.48Chi-squared
Secondary

Performance Time

Sum of imaging and performance time

Time frame: 1 Hour

ArmMeasureValue (MEAN)Dispersion
20 ml of Lidocaine 2% With EpinephrinePerformance Time10.9 minutesStandard Deviation 1.3
40 ml 0f Lidocaine 1% With EpinephrinePerformance Time9.1 minutesStandard Deviation 0.5
p-value: 0.001t-test, 2 sided
Secondary

Vascular Puncture

Incidence of vascular puncture during the performance of block.

Time frame: 1 Hour

ArmMeasureValue (NUMBER)
20 ml of Lidocaine 2% With EpinephrineVascular Puncture2 participants
40 ml 0f Lidocaine 1% With EpinephrineVascular Puncture1 participants
p-value: 0.53Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026