Trial Outcomes & Findings for Effect of Local Anaesthetic Dilution on the Characteristics of Ultrasound Guided Axillary Brachial Plexus Block (NCT NCT03207035)

NCT ID: NCT03207035

Last Updated: 2021-10-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2021-10-18

Participant Flow

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

Participant milestones

Measure	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	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
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 18.2 • n=5 Participants	48 years STANDARD_DEVIATION 15.7 • n=7 Participants	47.4 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Ireland	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Onset of Axillary Block	8.75 minutes Interval 7.5 to 10.0	6.25 minutes Interval 5.0 to 7.5

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Duration of Sensory and Motor Block	165.1 minutes Standard Deviation 5.9	150.9 minutes Standard Deviation 17.2

SECONDARY outcome

Timeframe: 1 Hour

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

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Block Performance Data- Imaging Time	2.5 minutes Standard Deviation 0.5	2.4 minutes Standard Deviation 0.6

SECONDARY outcome

Timeframe: 1Hour

Time taken to perform the block in minutes

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Needling Time	8.5 minutes Standard Deviation 1.2	6.7 minutes Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1 Hour

Sum of imaging and performance time

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Performance Time	10.9 minutes Standard Deviation 1.3	9.1 minutes Standard Deviation 0.5

SECONDARY outcome

Timeframe: 1 Hour

Number of needle passes while performing the axillary block

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
No of Needle Pass	10.5 Needle passes Standard Deviation 2.3	9.1 Needle passes Standard Deviation 0.5

SECONDARY outcome

Timeframe: 1 Hour

Incidence of vascular puncture during the performance of block.

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Vascular Puncture	2 participants	1 participants

SECONDARY outcome

Timeframe: 1 Hour

Incidence of parasthesia during the performance of axillary block

Outcome measures

Measure	20 ml of Lidocaine 2% With Epinephrine n=10 Participants 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	40 ml 0f Lidocaine 1% With Epinephrine n=10 Participants 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
Parasthesia	4 Parasthesia events	2 Parasthesia events

Adverse Events

20 ml of Lidocaine 2% With Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

40 ml 0f Lidocaine 1% With Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Anil Ranganath

Cork University Hospital

Email: drmrak.2@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place