Clinical trial NCT05649644: Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block
Official title: Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: A Randomized Superiority Trial Comparing Selective Trunk Block and Supraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Keywords: Sensorimotor Block Dynamics
Hemidiaphragmatic Palsy
Upper extremity surgery
Selective Trunk Block
Supraclavicular Brachial Plexus Block
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 50
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 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Readiness for surgery (Change of sensory and motor function from baseline to blockade)
timeFrame: Within 45 minutes after the block at 5 minutes interval
measure: Change of ipsilateral Hemidiaphragmatic (phrenic nerve) function from baseline to 30 minutes after SeTB
timeFrame: Before and 30 minutes after SeTB
Secondary outcomes:
measure: Complete sensory block
timeFrame: Within 45 minutes after the block at 5 minutes interval
measure: Motor blockade
timeFrame: Within 45 minutes after the block at 5 minutes interval
measure: Any occurrence of paradoxical movement
timeFrame: Within 45 minutes after the block
measure: Block performance time
timeFrame: Within 30 minutes after entering the procedure room
measure: Any occurrence of paresthesia
timeFrame: Immediately after the end of the block
measure: Discomfort score
timeFrame: Immediately after the end of the block]
measure: Any occurrence of symptomatic dyspnea
timeFrame: During and within 45 minutes after the block
measure: Name and dosage of used rescue analgesia
timeFrame: During surgery
measure: Total amount of local anesthetic infiltration used
timeFrame: During surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin, New Territories,
Study officials:
affiliation: Chinese University of Hong Kong
name: Manoj K Karmakar, MD
role: PRINCIPAL_INVESTIGATOR
References: