Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block

NCT05649644 | Recruiting

• 1 other identifier: 2022.219 SeTB vs SC BPB_RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound guided supraclavicular brachial plexus block (BPB) has been extensively studied and recommended as a sole anesthetic for upper extremity surgeries. The efficacy of ultrasound-guided (USG) SeTB for surgical anesthesia of the entire upper extremity and cadaver anatomic study evaluating the spread of the injectate after a simulated SeTB is further confirmed from the results of our previous research. Although the results in our previous study are encouraging, there is a paucity of data on sensorimotor blockade and incidence of hemidiaphragmatic palsy after a SeTB, and no data comparing SeTB with a supraclavicular BPB techniques which this study aims to evaluate. We hypothesise that USG SeTB is superior to supraclavicular BPB in anesthetising the entire upper extremity from the shoulder to hand.

Conditions

Musculoskeletal Diseases or Conditions

Keywords

Sensorimotor Block Dynamics; Hemidiaphragmatic Palsy; Upper extremity surgery; Selective Trunk Block; Supraclavicular Brachial Plexus Block

Outcome Measures

Primary Outcomes (2)

• Readiness for surgery (Change of sensory and motor function from baseline to blockade)

  When the patient is able to achieve a composite score of 20 out of 22 with a sensory blockade score of at least 9 out of 10. Sensory blockade:Loss of sensation to cold stimulus (ice cube) in the cutaneous distribution of the median, radial, ulnar, musculocutaneous and axillary nerves will be tested.Graded using a 3-points scale: 0 = able to feel touch and cold, 1= feel touch but not cold, 2 = feel neither touch nor cold. Motor blockade:The median, radial, ulnar, musculocutaneous, axillary and suprascapular nerves will be assessed.Graded using a 3-points scale: 0 = no block, 1 = paresis and 2 = paralysis.

  Within 45 minutes after the block at 5 minutes interval

• Change of ipsilateral Hemidiaphragmatic (phrenic nerve) function from baseline to 30 minutes after SeTB

  Reduction in diaphragmatic excursion of more than 75% of baseline, or no movement, or paradoxical movement will be considered as complete paresis. Reduction in diaphragmatic excursion of between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis. Each test will be performed 3 times, and values will be averaged.

  Before and 30 minutes after SeTB

Secondary Outcomes (9)

• Complete sensory block

  Within 45 minutes after the block at 5 minutes interval

• Motor blockade

  Within 45 minutes after the block at 5 minutes interval

• Any occurrence of paradoxical movement

  Within 45 minutes after the block

• Block performance time

  Within 30 minutes after entering the procedure room

• Any occurrence of paresthesia

  Immediately after the end of the block

Study Arms (2)

Selective Trunk Block (SeTB)

ACTIVE COMPARATOR

Patient who scheduled an upper extremity surgery involving anywhere from the proximal humerus to distal hand or surgery involving any combination of these regions and randomized in SeTB group will receive a SeTB.It will be performed through two skin punctures and as three separate injections to the three trunks of the brachial plexus.

Procedure: Selective Trunk Block (SeTB)

Supraclavicular Brachial Plexus Block (SC BPB)

ACTIVE COMPARATOR

Patient who scheduled an upper extremity surgery involving anywhere from the proximal humerus to distal hand or surgery involving any combination of these regions and randomized in SeTB group will receive a SC BPB. It will be performed using a single ultrasound window demonstrating the trunks and divisions of the brachial plexus in a superolateral position relative to the subclavian artery at the supraclavicular fossa.

Procedure: Supraclavicular Brachial Plexus Block (SC BPB)

Interventions

Selective Trunk Block (SeTB) PROCEDURE

Patient will lie supine on the examination couch with the ipsilateral arm in the neutral position (adducted), neck slightly extended and the head turned slightly to the contralateral side. After local anesthetic (LA) infiltration (1-2 ml lidocaine 1%), the nerve block needle will be inserted and placed within the interscalene groove. Then, a 7 ml of a 1:1 mixture of lidocaine 2% with 1:200,000 epinephrine and levobupivacaine 0.5% will be slowly injected in aliquots. After that, the tip will be redirected lateral to the middle trunk. A further 8 ml of the LA mixture will be injected after which the nerve block needle will be completely withdrawn. The transducer will then be manipulated to a sub-omohyoid position. After LA infiltration, the nerve block needle is inserted in-plane until the needle tip is positioned close to and lateral to (9-12 o'clock position) the inferior trunk. A 10 ml of the LA mixture is injected in small aliquots and the needle will be removed after the injection.

Selective Trunk Block (SeTB)

Supraclavicular Brachial Plexus Block (SC BPB) PROCEDURE

Patient will lie supine on the examination couch with the ipsilateral arm in the neutral position (adducted), neck slightly extended and the head turned slightly to the contralateral side. Patient will receive a subcutaneous infiltration with 1-2 ml of 0.9% normal saline (NS) at the superior and middle trunk level after which the needle will be completely withdrawn. Then, a local anesthetic (LA) infiltration (1-2 ml lidocaine 1%) will then be performed at the supraclavicular fossa and the nerve block will be inserted in-plane to place the needle tip at the corner pocket. After that, 15-ml of a 1:1 mixture of lidocaine 2% with 1:200,000 epinephrine and levobupivacaine 0.5% will be slowly injected in aliquots. Once completed, the needle tip is gently withdrawn and redirected into the cluster formed by the divisions of brachial plexus. Then, the remaining 10-ml of the same LA mixture will be injected in small aliquots and the needle will be removed after the injection.

Supraclavicular Brachial Plexus Block (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:

• ASA 1-3 patients
• Undergoing elective or emergency upper extremity surgery involving anywhere from the proximal humerus to distal hand or surgery involving any combination of these regions

You may not qualify if:

• Patient refusal
• Pregnancy
• Skin infection at the site of block placement
• History of allergy to local anaesthetic (LA) drugs
• Bleeding tendency or with evidence of coagulopathy
• Pre-existing respiratory disease
• 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, Hong Kong

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Manoj K Karmakar, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoi Ling Wong, RN, BN

CONTACT

+85255696157; aylawong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 1. Patients will be blinded to the group allocation. Patients will also be unable to view the ultrasound monitor during block placement. 2. The research nurse (outcome assessor) will not be present in the procedure room during block placement and will be blind to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomly allocated to receive either USG SeTB or supraclavicular BPB. The randomization sequence will be generated using an online randomization software (www.randomization.com) and prepared by a third party (Research assistant) not involved with the study. The randomization sequence will be assigned as 1 = SeTB group and 2 = SCBPB group and the group allocation card will be sealed within an opaque envelop by a research assistant.

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 14, 2022
• Study Start: May 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

HK (1)