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

NCT ID: NCT05649644

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2026-07-31

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.

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.

Conditions

Musculoskeletal Diseases or Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Selective Trunk Block (SeTB)

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.

Group Type: ACTIVE_COMPARATOR

Selective Trunk Block (SeTB)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Supraclavicular Brachial Plexus Block (SC BPB)

Intervention Type: 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.

Interventions

Selective Trunk Block (SeTB)

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.

Intervention Type: PROCEDURE

Supraclavicular Brachial Plexus Block (SC BPB)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof Manoj K Karmakar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manoj K Karmakar, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Hoi Ling Wong, RN, BN

Role: CONTACT

aylawong@cuhk.edu.hk

+85255696157

Facility Contacts

Angel Cheung, RN, BN, MSc

Role: primary

+85255696157

Other Identifiers

2022.219 SeTB vs SC BPB_RCT

Identifier Type: -

Identifier Source: org_study_id