Selective Trunk Block vs Hybrid Interscalene Supraclavicular BPB for Anaesthesia of the Entire Upper Extremity

NCT04908371 | Withdrawn

• 1 other identifier: SeTB vs IS-SC Ver2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the clinical effectiveness in producing anesthesia of the whole upper limb between two regional blocks - Selective Trunk Block (SeTB) and Hybrid Interscalene Supraclavicular Brachial Plexus Block (hybrid IS-SC BPB).

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Selective Trunk Block; Hybrid Interscalene-Supraclavicular Brachial Plexus Block

Outcome Measures

Primary Outcomes (2)

• Readiness for surgery

  An overall sensory score of =\<30 (loss of sensation to cold stimulus (ice cube), NRS: 100-0, 100=normal sensation, 0=no sensation) and motor score of =\<1 (3-points scale: 2=no block, 1=paresis, 0=paralysis) in all the nerves (C5 to T1) tested. Sensation block assessment: 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. Motor block assessment: C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).

  within 45 minutes after the block at 5 minutes interval

• Complete sensory-motor block

  An overall sensory score and motor score of '0'. Sensation to coldness (ice) with sensory score of '0' \[sensory score 100-0: sensory 100=normal sensation, and 0=no sensation\] for 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. Motor blockade will be graded using a 3-point scale: 2=no change, 1=reduced contraction (paresis), 0=paralysis. Motor block assessment at C5 - elbow flexors (biceps, brachialis), C6 - wrist extensors (extensor carpi radialis longus and brevis), C7 - elbow extensors (triceps), C8 - finger flexors (flexor digitorum profundus) to the middle finger, T1 - small finger abductors (abductor digiti minimi).

  within 45 minutes after the block at 5 minutes interval

Secondary Outcomes (6)

• Changes of sensory block of each nerve (C5 to T1)

  within 45 minutes after the block at 5 minutes interval

• Changes of motor block of each nerve (C5 to T1)

  within 45 minutes after the block at 5 minutes interval

• Block performance time

  within 30 minutes after entering the procedure room

• Discomfort score

  immediately after the end of the block

• Paresthesia

  immediately after the end of the block

Study Arms (2)

Selective Trunk Block (SeTB)

ACTIVE COMPARATOR

Patients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. After identifying the three trunks of the brachial plexus, ultrasound guided selective trunk block will be done using local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 20ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb.

Procedure: Selective Trunk Block

Interscalene-Supraclavicular Brachial Plexus Block (IS-SC-BPB)

ACTIVE COMPARATOR

Patients will lie flat on their back on the examination couch with the arm in neutral position and the head turned slightly to the opposite side. Ultrasound scan will be performed sequentially starting from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove. The unique sonomorphology of the C7 transverse process will be used as the key anatomical landmark to identify the individual elements of the brachial plexus. Under ultrasound guidance, local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 30ml) will be injected at the interscalene groove and at the supraclavicular fossa in order to anesthetize the whole upper limb.

Procedure: Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)

Interventions

Selective Trunk Block PROCEDURE

It is one type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 20ml) injected at the trunks of the brachial plexus in order to produce the anesthesia of the whole upper extremity of the patients scheduled for upper limb surgery. SeTB will be performed as a "two-injection technique". One at the side of the neck (interscalene groove) of the affected upper limb, injections will be made near the superior trunk (5mL) and follow by redirection of the needle under ultrasound guidance to inject the LA to middle trunk (5mL). Then the second skin puncture will be made near the upper part mid-collar bone (supraclavicular fossa) to inject the LA to the inferior trunk (10mL).

Also known as: Drug (Xylocaine with adrenaline and Chirocaine)

Selective Trunk Block (SeTB)

Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB) PROCEDURE

It is another type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 30ml) injected at the interscalene groove and supraclavicular fossa, so "two-injection technique" will be adopted. The first skin puncture will be near the side of the neck (interscalene groove) of the affected upper limb (15mL) and then the second skin puncture will also be made near the upper mid-collar bone (supraclavicular fossa) to inject 15mL of LA.

Also known as: Drug (Xylocaine with adrenaline and Chirocaine)

Interscalene-Supraclavicular Brachial Plexus Block (IS-SC-BPB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists (ASA) physical status I-III
• undergoing elective or emergency upper extremity surgery involving the proximal humerus to distal hand or surgery involving any combination of these regions scheduled for a brachial plexus block

You may not qualify if:

• Patient refusal
• Pregnancy
• Skin infection at the site of block
• History of allergy to local anesthetic agents
• Bleeding tendency or with evidence of coagulopathy
• Pre-existing neurological deficit or neuromuscular disease

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Pharmaceutical Preparations; Lidocaine; Epinephrine; Levobupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bupivacaine

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients in both study groups will not be able to see the ultrasound monitor during block placement and therefore will be blinded to group allocation. The "outcome assessor" (research nurse) will not be present in the procedure room during block placement and thus will also be blinded to group allocation. Dressings applied on the skin to cover the needle entry sites will also be identical in the two study groups. The anaesthesiologist (principal investigator) performing the allocated BPB will take no further part in the study after block placement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomly assigned to receive either a SeTB (SeTB group) or hybrid interscalene-supraclavicular BPB (IS-SC group) under ultrasound guidance. The randomization sequence will be generated using an online randomization software (www.randomization.com). The randomization sequence will be assigned as 1 = selective trunk block (SeTB group) and 2 = interscalene-supraclavicular BPB (IS-SC group). The group allocation will be prepared by a computer officer (third party) in the Department of Anaesthesia \& Intensive Care, of the Chinese University of Hong Kong.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

HK (1)