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Musculoskeletal Diseases or ConditionsNCT05649644

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

A study testing Selective Trunk Block (SeTB) and Supraclavicular Brachial Plexus Block (SC BPB) in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Musculoskeletal Diseases or Conditions
What is being tested?
Selective Trunk Block (SeTB) and Supraclavicular Brachial Plexus Block (SC BPB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
18 May 2023to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hoi Ling Wong, RN, BN contact

+85255696157

aylawong@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin, New Territories,

    Hong Kong

    Angel Cheung, RN, BN, MSc, +85255696157

    Manoj K Karmakar, MD

    Recruiting

Other trials in Hong Kong

About this study

Official title: Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: A Randomized Superiority Trial Comparing Selective Trunk Block and Supraclavicular Brachial Plexus Block

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.

Read the detailed description

Ultrasound guided supraclavicular brachial plexus block (BPB) has been extensively studied and recommended as a sole anesthetic for upper extremity surgeries. The supraclavicular BPB is often touted to be the 'spinal of the upper extremity' as it produces anesthesia of the entire upper extremity except for the T2 dermatome.

However, based on clinical experience, such a claim is grossly unsubstantiated. This is evident from the finding that supraclavicular BPB is associated with 2-36% inferior trunk or ulnar nerve sparing. In addition, since the suprascapular nerve takes off more proximally from the superior trunk and the supraclavicular BPB is performed distally at the supraclavicular fossa, the effect of supraclavicular BPB on the suprascapular nerve, which predominantly supply the shoulder and proximal humerus, is not known and has not been objectively documented.

Nonetheless, supraclavicular BPB has been successfully used for shoulder surgery albeit with a large local anesthetic (LA) volume (50-60 ml) or combined with interscalene BPB, a hybrid BPB technique using 30-50 ml LA volume, for proximal humerus fracture surgeries. But such high LA volume is invariably associated with potential complications in the high risk population and therefore not used in contemporary clinical practice.

Since all major nerves supplying the upper extremity, including suprascapular nerve, passes through the trunks of the brachial plexus, we proposed that by selectively identifying and blocking the three trunks of the brachial plexus with small doses of LA-selective trunk block (SeTB), it is feasible to produce anesthesia of the entire upper extremity, i.e., from shoulder to hand. This is further confirmed from the results of our research evaluating 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. Although these are encouraging results, there is a paucity of data on the sensorimotor blockade and incidence of hemidiaphragmatic palsy comparing SeTB and supraclavicular BPB techniques which this study aims to evaluate. We hypothesize that USG SeTB is superior to supraclavicular BPB in anesthetizing the entire upper extremity from shoulder to hand.

Being tested
Selective Trunk Block (SeTB), Supraclavicular Brachial Plexus Block (SC BPB)
Keywords
Sensorimotor Block Dynamics, Hemidiaphragmatic Palsy, Upper extremity surgery, Selective Trunk Block, Supraclavicular Brachial Plexus Block
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Selective Trunk Block (SeTB)Procedure or surgery

    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.

  • Supraclavicular Brachial Plexus Block (SC BPB)Procedure or surgery

    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.

Study groups in NCT05649644
Study groupRoleWhat they receive
Selective Trunk Block (SeTB)Active comparatorPatient 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.
Receives: Procedure: Selective Trunk Block (SeTB)
Supraclavicular Brachial Plexus Block (SC BPB)Active comparatorPatient 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.
Receives: Procedure: Supraclavicular Brachial Plexus Block (SC BPB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 45 minutes after the block at 5 minutes interval

  2. 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.

    Measured: Before and 30 minutes after SeTB

Secondary outcomes (9)
  1. Complete sensory block

    Sensory blockade score of at least 9 out of 10. 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.

    Measured: Within 45 minutes after the block at 5 minutes interval

  2. Motor blockade

    Motor blockade of the suprascapular nerve, 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.

    Measured: Within 45 minutes after the block at 5 minutes interval

  3. Any occurrence of paradoxical movement

    Any paradoxical movement after the block will be documented.

    Measured: Within 45 minutes after the block

  4. Block performance time

    The time taken from the start of the local anaesthetic (LA) skin infiltration to the end of the LA injection for the block.

    Measured: Within 30 minutes after entering the procedure room

  5. Any occurrence of paresthesia

    Any paresthesia experienced during the block will be assessed and recorded as a 'yes' or 'no' response.

    Measured: Immediately after the end of the block

  6. Discomfort score

    Discomfort experienced during the regional anesthesia using a numeric rating scale (NRS, 0 to 100, 0=no discomfort, 100=extreme discomfort)

    Measured: Immediately after the end of the block]

  7. Any occurrence of symptomatic dyspnea

    Any dyspnea experienced during and after the block will be assessed and recorded as a 'yes' or 'no' response.

    Measured: During and within 45 minutes after the block

  8. Name and dosage of used rescue analgesia

    Any rescue intravenous analgesic requirements during surgery will be documented with name and dosage.

    Measured: During surgery

  9. Total amount of local anesthetic infiltration used

    Any rescue LA infiltration requirements during surgery will be documented.

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start18 May 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05649644
Sponsor's protocol ID
2022.219 SeTB vs SC BPB_RCT
Status last verified
Apr 2025
First submitted
24 Nov 2022
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Selective Trunk Block (SeTB) and Supraclavicular Brachial Plexus Block (SC BPB) in people with Musculoskeletal Diseases or Conditions, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hoi Ling Wong, RN, BN (+85255696157, aylawong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readiness for surgery (Change of sensory and motor function from baseline to blockade) (time frame: Within 45 minutes after the block at 5 minutes interval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.

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