Comparison Between Epinephrine and Clonidine as Adjuvants to Lidocaine in Axillary Brachial Plexus Block.

August 7, 2021 updated by: Dr Anil Ranganath, Cork University Hospital

Comparison Between Epinephrine and Clonidine as Adjuvants to Lidocaine in Ultrasound Guided Axillary Brachial Plexus Block.

Adjuncts to local anaesthetics for the peripheral nerve blocks such as epinephrine, clonidine and opioids have been widely used to enhance quality, duration of anaesthesia and postoperative analgesia. Clonidine, an α2-adrenergic agonist, when combined with local anaesthetics in axillary brachial plexus block has shown to decrease block onset time and prolong the duration of anaesthesia.

We propose to compare the effects of combining both adjuvants to 20 mL of lidocaine 2% on the onset of ultrasound guided axillary brachial plexus block.

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

Using a 20 mL lidocaine 2% when combined with epinephrine 1:200 000 and clonidine 1 µg/kg will shorten the onset time of sensory block when compared to lidocaine 2% with epinephrine 1:200 000 alone in ultrasound guided axillary brachial plexus block for elective upper limb surgeries.

It is a prospective, randomized, observer blinded study. With institutional ethical approval and having obtained written informed consent from each, 24 patients will be studied.

Randomisation and blinding:

Using a computer generated and sealed envelope technique, 24 patients will be randomized in to one of two groups to receive ultrasound guided axillary brachial plexus block.

Group 1:

Patients will receive 20 ml of lidocaine 2% with epinephrine and 2 ml of 0.9% normal saline.

Group 2:

Patients will receive 20 ml of lidocaine 2% with epinephrine and clonidine 1µg/kg in 2 ml of 0.9% normal saline.

Sample size and Statistical analysis:

Sample size will be based on onset of block. Kaabachi et al16 found a sensory onset of axillary brachial plexus block (with 30 ml of lidocaine 1.5%) of 9 (SD, 3) mins. The sample size required to have an 90% probability of detecting a decrease in the onset time by 40% (level of significance 0.05)) will be 12 patients per group using an unpaired student's t test.

Anaesthetic procedure:

Having established intravenous access, standard anaesthetic monitoring will be applied. Sedation 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 ultrauplex short bevel insulated needle will be used with in-plane approach to block each nerve. 20 mL of Lidocaine 2% with epinephrine and 2ml of 0.9% Nacl(group 1) or clonidine 1µg/kg in 2 ml of 0.9% Nacl(group 2) will be divided equally among the 4 nerves. 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 block in the innervation of each nerve every 2.5 mins until complete sensory and motor block is achieved or 30 mins have elapsed . Complete sensory block is defined as absent sensation to cold and pinprick and complete motor block is defined as motor score ≤2. Each nerve distribution will be individually assessed. Onset time will be measured from conclusion of the block (t=0) to attainment of (surgical anaesthesia) complete sensory and motor block. Block will be deemed failure if sensory and motor block 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 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. 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 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.

Heart rate, arterial blood pressure, spo2 and sedation score (1=awake and alert, 2= sedated, responding to verbal stimulus, 3= sedated, responding to mild physical stimulus and 4=sedated, responding to moderate to severe physical stimulus) will be recorded intraoperatively every 5 mins and every 15 mins postoperatively for the first 4 hours. Hypotension and bradycardia, defined as 20% decrease in blood pressure and heart rate in relation to preblock value, will be recorded.

Primary Outcome:

The primary outcome will be onset of sensory block.

Secondary Outcomes:

  1. Onset of motor block.
  2. Duration of sensory and motor block
  3. The quality of block intra operatively
  4. The incidence of side effects in both groups. : sedation, hypotension, nausea, dizziness, tinnitus, vomiting convulsions or arrthymia

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.
24

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 1-2
  • Patients age >18 years
  • Undergoing elective upper limb (forearm, wrist or hand) surgery.

Exclusion Criteria:

  • Contraindications to regional anaesthesia
  • Hypersensitivity to amide local anaesthetics.
  • Chronic pain
  • Language barrier
  • Neuromuscular disorders or peripheral neuropathy
  • H/o postural hypotension or autonomic dysfunction.
  • Patients with a known sensitivity for local anaesthetics
  • Body mass index > 35
  • History of hepatic and renal insufficiency
  • Pregnancy
  • Cognitive or psychiatric disorder
  • Cardiac conduction abnormality.
  • Anti arrythmic or adrenergic medications.

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: lidocaine 2% with normal saline
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
Procedure: axillary brachial plexus block
ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
EXPERIMENTAL: lidocaine 2% with clonidine
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
Procedure: axillary brachial plexus block
ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine

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 Sensory Block
Time Frame: 1 day
Time taken for onset of sensory 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
Onset of Motor Block.
Time Frame: 1 day
time taken for onset of motor block of ultrasound guided axillary brachial plexus block
1 day
Duration of Sensory and Motor Block
Time Frame: 1 day
Total duration of sensory block of ultrasound guided axillary brachial plexus block
1 day

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anil Ranganath, 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.
June 11, 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.
July 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.
July 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.
September 2, 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.
August 7, 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.
August 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 (aa)

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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