Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05649644

Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin, New Territories,

Hong Kong

Location status: Recruiting

Location contact

Angel Cheung, RN, BN, MSc

CONTACT

+85255696157

Manoj K Karmakar, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

    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.

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

    Time frame: Before and 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.

Secondary outcomes

  1. Complete sensory block

    Time frame: Within 45 minutes after the block at 5 minutes interval

    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.

  2. Motor blockade

    Time frame: Within 45 minutes after the block at 5 minutes interval

    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.

  3. Any occurrence of paradoxical movement

    Time frame: Within 45 minutes after the block

    Any paradoxical movement after the block will be documented.

  4. Block performance time

    Time frame: Within 30 minutes after entering the procedure room

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

  5. Any occurrence of paresthesia

    Time frame: Immediately after the end of the block

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

  6. Discomfort score

    Time frame: Immediately after the end of the block]

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

  7. Any occurrence of symptomatic dyspnea

    Time frame: During and within 45 minutes after the block

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

  8. Name and dosage of used rescue analgesia

    Time frame: During surgery

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

  9. Total amount of local anesthetic infiltration used

    Time frame: During surgery

    Any rescue LA infiltration requirements during surgery will be documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Hoi Ling Wong, RN, BN

CONTACT

[email protected]

+85255696157

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2022
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.