Clinical trial NCT04773405: Minimum Effective Volume for Selective Trunk Block
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Keywords: Selective Trunk nerve block
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of sensory block of the upper extremity
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Changes of motor blockade of the upper extremity
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Readiness for surgery
timeFrame: within 45 minutes after the block at 5 minutes interval
Secondary outcomes:
measure: Changes of the Diaphragmatic function
timeFrame: Baseline (before block) and at 30 minutes after block
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References: