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

October 14, 2021 updated by: Dr Anil Ranganath, Cork University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 20 ml of lidocaine 2% with epinephrine
Patients will receive axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine.
Procedure: Axillary brachial plexus block
Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine
EXPERIMENTAL: 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)
Procedure: Axillary brachial plexus block
Ultrasound guided axillary brachial plexus block with local anaesthetic lidocaine with epinephrine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Onset of Axillary Block
Time Frame: 1 day
Time taken for onset of sensory and motor axillary brachial plexus block
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Sensory and Motor Block
Time Frame: 1 day
Total duration of sensory and motor block of ultrasound guided axillary brachial plexus block
1 day
Block Performance Data- Imaging Time
Time Frame: 1 Hour
Time taken to obtain appropriate ultrasound image to perform the axillary plexus block
1 Hour
Needling Time
Time Frame: 1Hour
Time taken to perform the block in minutes
1Hour
Performance Time
Time Frame: 1 Hour
Sum of imaging and performance time
1 Hour
No of Needle Pass
Time Frame: 1 Hour
Number of needle passes while performing the axillary block
1 Hour
Vascular Puncture
Time Frame: 1 Hour
Incidence of vascular puncture during the performance of block.
1 Hour
Parasthesia
Time Frame: 1 Hour
Incidence of parasthesia during the performance of axillary block
1 Hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cork University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECM 4 (mm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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