Phrenic Nerve Sparing of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery , Prospective Comparative Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis
研究概览
简要总结
Primarily, This study aims to compare between interscalene block alone versus combined with superior truncus block in producing diaphragmatic paralysis and Secondarily aims to evaluate
- Effect on the pulmonary function.
- Duration of the sensory and motor block.
- Postoperative analgesic consumption.
- Any complications or side effects during shoulder surgery.
详细描述
Regional anesthesia is central to modern shoulder surgery because it provides excellent perioperative analgesia, reduces opioid consumption, and facilitates early rehabilitation. The interscalene brachial plexus block (ISB) has long been considered the gold-standard single-shot regional technique for shoulder procedures due to its reliable analgesia and surgical anesthesia. However, ISB commonly causes ipsilateral hemidiaphragmatic paresis (HDP) from unintended phrenic nerve blockade, which can produce clinically important declines in pulmonary function and may be poorly tolerated in patients with limited respiratory reserve.
To minimize phrenic involvement while preserving analgesic effectiveness, more selective approaches have been proposed. The superior trunk block (STB) - performed at the level where C5-C6 fibers form the superior trunk - aims to anesthetize the shoulder innervation more distally and thus reduce spread to the phrenic nerve. A landmark randomized trial and subsequent studies reported that STB provides analgesia comparable to ISB while greatly lowering the incidence of HDP (for example, ISB 71% vs STB 5% in one trial). Systematic reviews and meta-analyses since then have reinforced STB as an effective phrenic-sparing alternative for many shoulder procedures.
Despite encouraging data for STB, the literature is not entirely uniform. Some randomized trials and observational reports have found either reduced anesthetic quality with STB or smaller-than-expected reductions in phrenic involvement, particularly when block technique, local anesthetic volume, or patient anatomy differ. Moreover, combining blocks (for example, ISB with selective superior-trunk targeting or other modifications) has been proposed as a strategy to balance surgical anesthesia and respiratory safety, but comparative prospective data examining the effect of ISB alone versus ISB combined with STB on diaphragmatic function are limited. This uncertainty is important because even partial diaphragmatic paresis can degrade postoperative pulmonary mechanics and increase complications in vulnerable patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anesthesiologists) I, II physical status.
- •Aged between 20 and 65 years.
- •Male or female.
- •Body Mass index (BMI): 18-30 kg/m
- •Scheduled for shoulder surgery.
排除标准
- •Allergy to local anesthetics.
- •Infection at the injection site.
- •Coagulation disorders.
- •Respiratory diseases ( Acute or Chronic) or Chest trauma.
- •Multiple traumatized patients.
- •Phrenic nerve injury
- •Heart failure, Cardiomyopathy.
- •Severe organ dysfunction
- •Patient refusal
研究组 & 干预措施
Interscalene block alone
Interscalene block alone, we will inject 20 mL of 0.5 % bupivacaine plus 10 mL of 0.9 % normal saline around brachial plexus in the interscalene site under ultrasonograhy.
干预措施: Regional anesthesia in shoulder surgery (Other)
Interscalene block plus Superior truncus block
- We will inject 7 mL of 0.5 % bupivacaine plus 3 mL of 0.9 % normal saline ( Total amount 10 ml) around brachial plexus in the interscalene site under ultrasonograhy.
- Also we will inject 13 mL of 0.5 % bupivacaine plus 7 mL of 0.9 % normal saline ( Total amount 20 ml) around Superior trunk of brachial plexus under ultrasonagraphy.
干预措施: Regional anesthesia in shoulder surgery (Other)
结局指标
主要结局
Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis
时间窗: Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block.
Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block. To measure DE, patients will be placed in a supine position, a convex transducer (3.5 \~ 5 MHz) will be used to scan while the right diaphragm through the hepatic window and the left diaphragm through the splenic window, which located near the anterior-axillary line. The craniocaudal movement of the diaphragm will be documented during deep inspiration using M-mode. * Complete diaphragmatic paralysis was defined as a 75% \~ 100% reduction in DE, including the occurrence of paradoxical movement. * Partial diaphragmatic paralysis was defined as a 25% \~ 75% reduction in DE. * No diaphragmatic paralysis was indicated by a DE reduction of less than 25%. To measure TF, patients will be placed in the same position with the head of the bed at 45°degree
次要结局
- Evaluation of the interscalene block alone versus combined with superior truncus block during shoulder surgery on the pulmonary function(Assessment of pulmonary function by a handheld spirometer to measure forced vital capacity (FVC), forced expiratory volume ( FEV1, FEV2) with patients in an upright-seated position pre-block and 30 minutes post-block as well as 2-hours post-surgery)
- Duration of the sensory and motor block onset, duration of the interscalene block alone versus combined with superior truncus block during shoulder surgery(Sensory, motor block onset time every minute. Sensory, Motor block duration every hour in 1st 6 hours , every 2 hours in 2nd 6 hours)
- Evaluation of postoperative analgesic consumption(12 hours)
- Evaluation of any complications or side effects during shoulder surgery(24 hours)
研究者
Sherif Salah Ismail
Assistant lecturer of Anesthesia and ICU and Pain Management of Sohag University hospital
Sohag University
