Skip to main content
OpenTrials
Completed

NCT Number: NCT03207035

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

axillary brachial plexus block

Procedure

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

Primary outcomes

  1. Onset of Axillary Block

    Time frame: 1 day

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

Secondary outcomes

  1. Duration of Sensory and Motor Block

    Time frame: 1 day

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

  2. Block Performance Data- Imaging Time

    Time frame: 1 Hour

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

  3. Needling Time

    Time frame: 1Hour

    Time taken to perform the block in minutes

  4. Performance Time

    Time frame: 1 Hour

    Sum of imaging and performance time

  5. No of Needle Pass

    Time frame: 1 Hour

    Number of needle passes while performing the axillary block

  6. Vascular Puncture

    Time frame: 1 Hour

    Incidence of vascular puncture during the performance of block.

  7. Parasthesia

    Time frame: 1 Hour

    Incidence of parasthesia during the performance of axillary block

Sponsors and collaborators

Lead sponsor

Cork University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2017
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.