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

NCT ID: NCT04908371

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-01-31

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).

Detailed Description

Brachial plexus block (BPB) is frequently used as the sole anesthestic technique for upper extremity surgery. The choice of injection can be made from different approaches that often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the approach used. However, there is no single BPB technique that can consistently produce anesthesia of the whole ipsilateral upper extremity. Nevertheless, cases such as combined fracture of the upper humerus and forearm bones have to anesthetize the whole upper extremity for surgery or those with multiple comorbidities and unfit for general anesthesia. In these cases, multiple injections have to be made. Thus, a combined ultrasound guided (USG) interscalene-supraclavicular (IS-SC) BPB has to be used as the sole anesthetic for proximal humerus surgery but with a relatively large volume (35-50mL) of numbing medication, which often exceed the recommended maximum safety dose. Recently principal investigator has demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. As majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, principal investigator has proposed that selectively blocking the superior, middle and inferior trunks of the brachial plexus under ultrasound guidance, will produce anesthesia of the entire upper limb. Principal investigator refers this technique as selective trunk block (SeTB). The preliminary experience with SeTB for anesthesia of the entire upper limb with smaller volumes (25ml) of numbing medication is feasible and able to ensure total immobility of the whole upper limb that meets the essential requirement for surgery. In this study principal investigator hypothesizes that USG guided SeTB is not inferior to USG IS-SC BPB in terms of its ability to produce sensory-motor blockade.

The aim of this study is to compare the proportion of patients who develop "readiness for surgery" for 30 minutes between a SeTB and hybrid IS-SC BPB. In other words, comparing the clinical effectiveness in producing anesthesia of the whole ipsilateral upper limb between SeTB and hybrid IS-SC brachial plexus block.

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)

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.

Group Type: ACTIVE_COMPARATOR

Selective Trunk Block

Intervention Type: 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).

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

Selective Trunk Block

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).

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Other Intervention Names

Drug (Xylocaine with adrenaline and Chirocaine); Drug (Xylocaine with adrenaline and Chirocaine)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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

Countries

Hong Kong

Other Identifiers

SeTB vs IS-SC Ver2

Identifier Type: -

Identifier Source: org_study_id