Clinical trial NCT04908371: Selective Trunk Block vs Hybrid Interscalene Supraclavicular BPB for Anaesthesia of the Entire Upper Extremity
Official title: Selective Trunk Block Versus Hybrid Interscalene-Supraclavicular Brachial Plexus Block for Anaesthesia of the Entire Upper Extremity: A Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Keywords: Selective Trunk Block
Hybrid Interscalene-Supraclavicular Brachial Plexus Block
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to receive either a SeTB (SeTB group) or hybrid interscalene-supraclavicular BPB (IS-SC group) under ultrasound guidance. The randomization sequence will be generated using an online randomization software (www.randomization.com). The randomization sequence will be assigned as 1 = selective trunk block (SeTB group) and 2 = interscalene-supraclavicular BPB (IS-SC group). The group allocation will be prepared by a computer officer (third party) in the Department of Anaesthesia \& Intensive Care, of the Chinese University of Hong Kong.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Readiness for surgery
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Complete sensory-motor block
timeFrame: within 45 minutes after the block at 5 minutes interval
Secondary outcomes:
measure: Changes of sensory block of each nerve (C5 to T1)
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Changes of motor block of each nerve (C5 to T1)
timeFrame: within 45 minutes after the block at 5 minutes interval
measure: Block performance time
timeFrame: within 30 minutes after entering the procedure room
measure: Discomfort score
timeFrame: immediately after the end of the block
measure: Paresthesia
timeFrame: immediately after the end of the block
measure: Complications
timeFrame: within 45 minutes after the block
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References: