Selective Trunk Block: A Study to Evaluate Block Dynamics, Effects and Efficacy for Upper Limb Surgery

NCT04752410 | Completed

• 1 other identifier: Updated SeTB (CREC.2020.308)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity. However, occasionally surgery entails that the whole upper extremity, 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. This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" \[NCT04510259\] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol. 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.

Conditions

Upper Extremity Problem

Keywords

Brachial plexus block; Upper extremity

Outcome Measures

Primary Outcomes (3)

• 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) and axillary (skin over the lower deltoid) 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

• Changes of motor block 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 anesthetized 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) abduction of shoulder (axillary nerve), and external rotation of the arm with elbow flexed and simulate emptying a can motion and test for power against resistance (Suprascapular 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 nerves functions.

  within 45 minutes after the block at 5 minutes interval

• 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 nerves tested.

  within 45 minutes after the block at 5 minutes interval

Secondary Outcomes (1)

• Changes of the Diaphragmatic function

  Baseline (before brachial plexus block) and at 30 minutes after block

Study Arms (1)

Selective Brachial plexus block

EXPERIMENTAL

Selective brachial plexus block will be done under ultrasound guidance to patients scheduled for upper extremity surgeries. Local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 25ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb.

Procedure: Selective Brachial Plexus Block

Interventions

Selective Brachial Plexus Block PROCEDURE

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.

Also known as: Drug

Selective Brachial plexus block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective upper extremity surgery
• emergency upper extremity surgery

You may not qualify if:

• Patient refusal
• pregnancy
• local skin site infection
• allergy to local anesthetics
• bleeding tendency
• pre-existing neurological deficit
• pre-existing neuromuscular disease.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Shatin, Kowloon, Hong Kong

Location

Related Publications (1)

• Sivakumar RK, Samy W, Pakpirom J, Songthamwat B, Karmakar MK. Ultrasound-guided selective trunk block: Evaluation of ipsilateral sensorimotor block dynamics, hemidiaphragmatic function and efficacy for upper extremity surgery. A single-centre cohort study. Eur J Anaesthesiol. 2022 Oct 1;39(10):801-809. doi: 10.1097/EJA.0000000000001736. Epub 2022 Aug 11.

  PMID: 35950709 DERIVED

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: February 19, 2021
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

HK (1)