Selective Trunk Brachial Plexus Block

Upper Extremity Problem Clinical Trial

Official title:

Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510259
• Other study ID #: SeTB
• Status: Completed
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: July 27, 2021

Study information

• Verified date: July 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brachial plexus block (BPB) is frequently used as the sole anesthestic technique for upper extremity surgery. However, the choice of injection can be made from different approaches that often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the approach used. The investigator is not aware of any single BPB technique that can consistently produce surgical anaesthesia of the whole ipsilateral upper extremity. However, occasionally surgery entails that the whole upper extremity is anesthetized, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthetsia of the whole ipsilateral upper extremity. The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

Description:

Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery. The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used. The investigator is not aware of any single BPB technique that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity. However, occasionally surgery entails that the whole upper extremity is anesthetized, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking upper, middle and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity, except for the area innervated by the intercostobrachial nerve (T2- medial aspect of the upper arm). In addition, there may be a potential advantage that phrenic nerve can be spared, so this blockade will not affect the respiratory function as it is common to see phrenic nerve palsy after interascalene BPB (100%) and supraclavicular BPB (50-67%). The aim of this study is therefore to assess a novel brachial plexus block technique, the "selective trunk block" (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Elective upper extremity surgery

• Emergency upper extremity surgery

Exclusion Criteria:

• Patient refusal

• Local skin site infection

• Allergy to local anaesthetics

• Peripheral neuropathy

• Brachial plexopathy

Related Conditions & MeSH terms

• Upper Extremity Problem

Intervention

Procedure:
• Selective Brachial plexus Block
It is one type of peripheral nerve blocks for upper extremity surgery. In this study, the block will be done under the ultrasound guidance and the local anesthetic agent (a mixture of 2% Xylocaine with 1: 200,000 adrenaline and 0.5% Chirocaine in a total of 25ml) will be injected at the trunks of the brachial plexus in order to produce the surgical anesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.

Locations

Country	Name	City	State
Hong Kong	Department of Anaesthesia & Intensive Care, Prince of Wales Hospital	Shatin	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of sensory block of the upper extremity	Sensation to coldness (ice) will be tested at the median (lateral three and half digits on the palmar side), radial (dorsal side of hand), ulnar (medial one and a half digits), musculocutaneous (lateral side of the forearm), axillary (skin over the lower deltoid) and supra scapular nerve (skin over the scapula) and graded using a verbal rating scale (VRS: 0-100, 100=normal sensation, 0=no sensation). Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of = 30.	within 45 minutes after the block at 5 minutes interval
Primary	Changes of motor blockade of the upper extremity	Motor blockade will be graded using a 3-points scale revising from previous study: 2 = no block, 1 = paresis and 0 = paralysis. Motor blockade of each individual nerve in the anaesthetized upper extremity will be evaluated by testing for opposition of thumb with the index finger (median nerve), wrist extension (radial nerve), thumb opposition with little finger (ulnar nerve), elbow flexion (musculocutaneous nerve) and abduction of shoulder (axillary nerve). The onset of motor block for each nerve will be defined as motor grading at each nerve = 1. Complete block will be defined as a sensory and motor block score of '0' in all five nerve (median, ulnar, radial, musculocutaneous nerve and axillary) functions and a sensory score of '0' at Suprascapular nerve dermatome.	within 45 minutes after the block at 5 minutes interval
Primary	Readiness for surgery	Overall sensory scores = 30 (VRS: 0-100, 100=normal sensation, 0=no sensation) and motor score = 1 (3-points scale: 2=no block, 1=paresis, 0= paralysis) in all the five nerves tested.	within 45 minutes after the block at 5 minutes interval
Secondary	Changes of the Diaphragmatic function	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.	Baseline(before brachial plexus block) and at 30 minutes after block