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Effect of Local Anaesthetic Volume on Axillary Brachial Plexus Block Duration

A Comparison of the Effects of Two Volumes (10 vs 30 mL) of Lidocaine 2% With Epinephrine 1:200 000 on the Duration of Ultrasound Guided Axillary Brachial Plexus Block.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03163472
Enrollment
30
Registered
2017-05-23
Start date
2012-11-14
Completion date
2013-08-07
Last updated
2021-10-04

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

Axillary brachial plexus block is an safe, effective and widely used technique for providing surgical anesthesia at and below the elbow. Inadvertent intraneural and intravascular injections are the only significant risks. Traditionally, greater volumes of local anaesthetic have been administered to achieve successful axillary brachial plexus block, but recent studies have demonstrated that this can be achieved with even very low volumes of 2-4 mL lidocaine 1.5% per nerve or ultra low volume of 1 mL lidocaine 2% per nerve. Administration of 30mL (vs 10 mL) lidocaine 2% with epinephrine 1:200 000 prolongs the sensory and motor block duration of ultrasound guided axillary brachial plexus block for elective upper limb surgical procedures. Primary Outcome: The primary outcome will be the overall duration of sensory block. Secondary Outcomes: Duration of motor block Time to onset of the block. The quality of block intraoperatively Time to first request of postoperative opioid analgesia. Total opioid consumption at 24 hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.

Detailed description

Peripheral nerve blocks provide significant benefits to patients, including improved analgesia and decrease in general anaesthesia-related adverse effects. Ideally peripheral nerve block provides rapid onset and substantial perioperative analgesia. Use of ultrasound guidance in peripheral nerve blocks offers significant advantages compared to alternative techniques. It improves block success rate and shortens onset time. To compare the effects of local anaesthetic volumes (10 vs 30 mL) of lidocaine 2% with epinephrine 1:200 000 on the duration 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, 30 patients will be studied. Randomization and blinding: Using a computer generated and sealed envelope technique, 30 patients will be randomly allocated in to one of two groups. Group 1: patients will receive 10 ml of lidocaine 2% with epinephrine. Group 2: patients will receive 30 ml of lidocaine 2% with epinephrine. Sample size and statistical analysis: Sample size calculation will be based on duration of sensory block as the primary outcome parameter. Kaabachi et al found a sensory duration of axillary brachial plexus block (with 30 mL of lidocaine 1.5%) of 126 (SD=48) mins. The minimum sample size required to have a 90% probability of detecting a decrease in duration of 60 mins (level of significance 0.05) will be 13 patients per group using an unpaired student's t test. Total recruited 30. 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 22-gauge ultraplex short bevel insulated needle will be used with in-plane approach to block each nerve with either 2.5 ml (10 mL group) or 7.5 ml (30 mL group). All blocks will be performed by single 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 block15 in the innervation of each nerve every 5 mins, until surgical anesthesia is achieved or 30 mins have elapsed. Surgical anesthesia 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 anesthesia. Block will be deemed failure if surgical anesthesia 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 anesthesia 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 of 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: The primary outcome will be the overall duration of sensory block. Secondary Outcomes: Duration of motor block Time to onset of the block. The quality of block intraoperatively Time to first request of postoperative opioid analgesia. Total opioid consumption at 24 hours. The incidence of adverse effects perioperatively: nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia.

Interventions

PROCEDUREAxillary brachial plexus block with 10 mL oof local anaesthetic

patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.

PROCEDUREAxillary brachial plexus block with 30 ml of local anaesthetic

patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% 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, wrist 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
Overall Duration of Sensory Block.24 hoursDuration of sensory block of ultrasound guided brachial plexus block

Secondary

MeasureTime frameDescription
Duration of Motor Block24 hoursThe total duration of motor block
Time to Onset of the Block6 hoursTime to overall onset time for block
Time to First Request of Postoperative Opioid Analgesia24 hoursPost-operative, Time to first request of opioid analgesia by the participants
Opioid Consumption24 hoursoverall cumulative opioid consumption dose of the participants
Number of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia24 hoursWe recorded the the number of participants with adverse effects like nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia during the perioperative period.

Participant flow

Pre-assignment details

Assessed for eligibility: n= 60 Excluded : n=30 * Not meeting inclusion criteria: n = 5 * Declined to participate: n= 25

Participants by arm

ArmCount
10 ml of Lidocaine 2% With Epinephrine
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine. Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
15
30ml of Lidocaine 2% With Epinephrine
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine. Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
15
Total30

Baseline characteristics

Characteristic10 ml of Lidocaine 2% With Epinephrine30ml of Lidocaine 2% With EpinephrineTotal
Age, Continuous49 years
STANDARD_DEVIATION 15.1
50 years
STANDARD_DEVIATION 22.1
49.3 years
STANDARD_DEVIATION 18.6
Sex: Female, Male
Female
7 Participants6 Participants13 Participants
Sex: Female, Male
Male
8 Participants9 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

Primary

Overall Duration of Sensory Block.

Duration of sensory block of ultrasound guided brachial plexus block

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
10 ml of Lidocaine 2% With EpinephrineOverall Duration of Sensory Block.165 minutes
30ml of Lidocaine 2% With EpinephrineOverall Duration of Sensory Block.188 minutes
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

Duration of Motor Block

The total duration of motor block

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
10 ml of Lidocaine 2% With EpinephrineDuration of Motor Block165 minutes
30ml of Lidocaine 2% With EpinephrineDuration of Motor Block195 minutes
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary

Number of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia

We recorded the the number of participants with adverse effects like nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia during the perioperative period.

Time frame: 24 hours

Population: No adverse events noted in any participants in either group

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
10 ml of Lidocaine 2% With EpinephrineNumber of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia0 Participants
30ml of Lidocaine 2% With EpinephrineNumber of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia0 Participants
Secondary

Opioid Consumption

overall cumulative opioid consumption dose of the participants

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
10 ml of Lidocaine 2% With EpinephrineOpioid Consumption8.3 mgStandard Deviation 5.6
30ml of Lidocaine 2% With EpinephrineOpioid Consumption6.3 mgStandard Deviation 6.9
Secondary

Time to First Request of Postoperative Opioid Analgesia

Post-operative, Time to first request of opioid analgesia by the participants

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
10 ml of Lidocaine 2% With EpinephrineTime to First Request of Postoperative Opioid Analgesia188 minutes
30ml of Lidocaine 2% With EpinephrineTime to First Request of Postoperative Opioid Analgesia267 minutes
p-value: 0.011Wilcoxon (Mann-Whitney)
Secondary

Time to Onset of the Block

Time to overall onset time for block

Time frame: 6 hours

ArmMeasureValue (MEDIAN)
10 ml of Lidocaine 2% With EpinephrineTime to Onset of the Block15 minutes
30ml of Lidocaine 2% With EpinephrineTime to Onset of the Block10 minutes
p-value: 0.022Wilcoxon (Mann-Whitney)

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