Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: A Randomized Superiority Trial Comparing Selective Trunk Block and Supraclavicular Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Readiness for surgery (Change of sensory and motor function from baseline to blockade)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- Patients will be blinded to the group allocation. Patients will also be unable to view the ultrasound monitor during block placement.
- The research nurse (outcome assessor) will not be present in the procedure room during block placement and will be blind to group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Readiness for surgery (Change of sensory and motor function from baseline to blockade)
时间窗: 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.
Change of ipsilateral Hemidiaphragmatic (phrenic nerve) function from baseline to 30 minutes after SeTB
时间窗: 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.
次要结局
- Block performance time(Within 30 minutes after entering the procedure room)
- Discomfort score(Immediately after the end of the block])
- Any occurrence of paresthesia(Immediately after the end of the block)
- Complete sensory block(Within 45 minutes after the block at 5 minutes interval)
- Any occurrence of paradoxical movement(Within 45 minutes after the block)
- Any occurrence of symptomatic dyspnea(During and within 45 minutes after the block)
- Name and dosage of used rescue analgesia(During surgery)
- Motor blockade(Within 45 minutes after the block at 5 minutes interval)
- Total amount of local anesthetic infiltration used(During surgery)
研究者
Prof Manoj K Karmakar
Professor
Chinese University of Hong Kong