- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773405
Minimum Effective Volume for Selective Trunk Block
November 16, 2021 updated by: Prof Manoj K Karmakar, Chinese University of Hong Kong
Minimum Effective Local Anaesthetic Volume of a 1:1 Mixture of 2% Lidocaine With 5ug/ml of Epinephrine and 0.5% Levobupivacaine Required for Ultrasound Guided Selective Trunk Block: A Dose Finding Study
The objective of this study is to identify the minimum effective dosage of a mixture of two local anaesthetic drugs called 'levobupivacaine' and 'lignocaine with epinephrine" used to produce an effective ultrasound guided selective trunk block for surgical anaesthesia of the upper limb.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ultrasound is widely used for brachial plexus block (BPB) and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks.
Since majority of the innervation to the upper extremity, including the shoulder, arises from the three trunks (superior, middle and inferior) of the brachial plexus, so targeted injections of the individual trunks of the brachial plexus under ultrasound guidance will produce surgical anaesthesia of the entire upper extremity (C5-T1).
Principal Investigator refers to this novel technique "selective trunk block" (SeTB) and the preliminary experience with SeTB for surgical anaesthesia of the entire upper extremity has been very encouraging.
Currently there are no data describing an optimal dose or volume of local anaesthetic for SeTB.
The aim of this study is to identify the minimum dosage of 1:1 mixture of 'levobupivacaine' and "lignocaine with epinephrine" required to produce effective surgical anaesthesia in at least 90% of patients presented for upper limb surgery.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Territories
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Shatin, New Territories, Hong Kong
- Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
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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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions.
Exclusion Criteria:
- Patient refusal
- pregnancy
- skin infection at the site of block placement
- history of allergy to local anaesthetic drugs
- history of bleeding tendency or with evidence of coagulopathy
- pre-existing neurological deficit
- pre-existing neuromuscular disease.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Selective Trunk Block
Selective trunk block will be done under ultrasound guidance to patients scheduled for upper extremities surgeries.
Local anaesthetic agents (a 1:1 mixture of 2% lidocaine with 5ug/ml of epinephrine and 0.5% levobupivacaine) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anaesthetize the whole upper limb.
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This study adopts a "Modified Narayana rule (MNR)", a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELAV90) of cases of the aforementioned local anaesthetic (LA) mixture, in order to produce the surgical anaesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.
Based on the principal investigator's clinical experience, the initial volume of 21ml will be used.
Depending on the success or failure of the SeTB, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 3ml (1ml for each trunk of brachial plexus located above the clavicle).
The upper dose limit of the study to minimize the potential for local anaesthetic systemic toxicity will be 30ml and the lower dose limit will be 12ml, which will be of no clinical importance.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of sensory block of the upper extremity
Time Frame: within 45 minutes after the block at 5 minutes interval
|
Sensation to coldness (ice) will be tested at C5 - Lateral (radial) side of the antecubital fossa (just proximal to elbow crease), C6 - Thumb, dorsal surface, proximal phalanx, C7 - middle finger, dorsal surface, proximal phalanx, C8 - Little finger, dorsal surface, proximal phalanx, and T1 - medial (ulnar) side of the antecubital) fossa, just proximal to the medial epicondyle of the humerus.
Sensory block, defined as loss of sensation to cold (ice), will be graded using a numeric rating scale (NRS: 0-100, 100=normal sensation, 0=no sensation).
A 3-point qualitative sensory score (0=no block, 1=analgesia/ patient can feel touch but not cold, and 2=anaesthesia / patient cannot feel touch) will be used.
Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of NRS =<30 and Qualitative sensory score =1 .
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within 45 minutes after the block at 5 minutes interval
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Changes of motor blockade of the upper extremity
Time Frame: within 45 minutes after the block at 5 minutes interval
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motor blockade will be graded using a 3-point scale: 0=no block, 1=paresis and 2=paralysis.
Motor blockade of each individual nerve in the anaesthetized upper extremity will be evaluated by testing C5 - elbow flexors, C6 - Wrist extensors, C7 - Elbow extensors, C8 - Finger flexors to the middle finger, and T1 - small finger abductors.
Onset of Motor block for each nerve will be defined as the time it took to achieve motor score >=1.
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within 45 minutes after the block at 5 minutes interval
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Readiness for surgery
Time Frame: within 45 minutes after the block at 5 minutes interval
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Overall sensory score of NRS =<30 (NRS: 0-100; 100=normal sensation, 0=no sensation) and Qualitative sensory score =1 for each nerve; and motor scores >=1 (3 point scale: 0=no block, 1=paresis, 2=paralysis) in all nerves tested.
Overall the maximum composite sensory-motor score achievable is 20 points (2 points for each 5 sensory nerves tested and 2 points for each 5 motor nerves tested).
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within 45 minutes after the block at 5 minutes interval
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of the Diaphragmatic function
Time Frame: Baseline (before block) and at 30 minutes after block
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Excursion of the right hemidiaphragm will be measured by ultrasound machine in supine position via the anterior subcostal route.
The movement of the diaphragm will be measured in centimetres.
The range of diaphragmatic excursion will be recorded from the resting expiratory position to deep inspiration (sigh test) as will be the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test).
The decrease in diaphragmatic excursion will be calculated as the difference (in %) in diaphragmatic excursion measured before and 30 minutes after SeTB.
Reduction in diaphragmatic excursion of more than 75%, or no movement, or paradoxical movement will be considered as complete paresis.
Reduction in diaphragmatic excursion of both sigh and sniff test between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis'.
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Baseline (before block) and at 30 minutes after block
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 10, 2021
Primary Completion (Actual)
November 12, 2021
Study Completion (Actual)
November 17, 2021
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
February 26, 2021
Study Record Updates
Last Update Posted (Actual)
November 18, 2021
Last Update Submitted That Met QC Criteria
November 16, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Levobupivacaine
- Epinephrine
Other Study ID Numbers
- SeTB MEV Ver 4
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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