Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Incidence of hemi-diaphragmatic paresis
研究概览
简要总结
Shoulder surgery causes significant postoperative pain, and ultrasound-guided regional anesthesia is central to its management. The interscalene block (ISB) is the gold standard but frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis, limiting its use in patients with reduced pulmonary reserve. The suprascapular (SSNB) and costoclavicular (CCB) blocks are proposed diaphragm-sparing alternatives, but data directly comparing all three are limited.
This randomised, double-blinded trial will compare the incidence of hemi-diaphragmatic paresis among ultrasound-guided ISB, SSNB, and CCB in elective shoulder surgery. Seventy-five ASA I-II patients aged 18-70 will be allocated 1:1:1 to one block. The primary outcome is the incidence of hemi-diaphragmatic paresis, measured by ultrasound diaphragmatic excursion before induction and after recovery in the PACU. Secondary outcomes include postoperative pain, analgesic consumption, and patient satisfaction. The investigators hypothesise that SSNB and CCB will cause less hemidiaphragmatic paresis than ISB while providing comparable analgesia.
详细描述
This randomized, double-blinded, parallel-group trial compares the effect of three ultrasound-guided regional anesthesia techniques on diaphragmatic function in elective shoulder surgery. The interscalene block (ISB), the gold standard, frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis. The suprascapular (SSNB) and costoclavicular (CCB) blocks preserve analgesia while sparing the phrenic nerve, but direct comparative data among all three are limited.
Seventy-five ASA I-II patients aged 18-70 scheduled for elective shoulder surgery will be randomized 1:1:1 (25 per group) using computer-generated allocation with sealed opaque envelopes. ISB: 10 mL 0.25% bupivacaine with dexmedetomidine 0.5 µg/kg; SSNB: 10 mL of the same mixture; CCB: 20 mL of the same mixture. All blocks are ultrasound-guided and performed before a standardised general anaesthetic.
Diaphragmatic excursion is measured by M-mode ultrasound of both hemidiaphragms at baseline (pre-induction), 30 minutes after the block, and in the PACU at a train-of-four ratio ≥0.9. Hemi-diaphragmatic paresis is graded as Complete (>75% reduction or paradoxical movement), Partial (25-75%), or Normal (0-25%). The primary outcome is its incidence. Secondary outcomes include VAS pain at rest and movement (1, 3, 6, 12, 24 h), analgesic consumption, time to first rescue analgesia, block performance time, complications, and patient satisfaction.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sexes, aged 18 to 70 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective shoulder surgery
排除标准
- •Pulmonary disease or baseline diaphragmatic dysfunction Refusal to provide informed consent Pre-existing neuropathy in the operated limb Allergy to local anesthetics Infection at the injection site Coagulopathy Pregnancy
结局指标
主要结局
Incidence of hemi-diaphragmatic paresis
时间窗: From pre-induction baseline to PACU assessment at train-of-four ratio ≥0.9 (up to approximately 24 hours after the block
Incidence of hemi-diaphragmatic paresis assessed by M-mode ultrasound measurement of diaphragmatic excursion, comparing post-block values to the pre-induction baseline. Hemi-diaphragmatic paresis is defined as a \>75% reduction in diaphragmatic excursion from baseline or paradoxical diaphragmatic movement (complete paresis); a 25-75% reduction is classified as partial paresis. Measured in the PACU after recovery of muscle power (train-of-four ratio ≥0.9). Reported as the number/percentage of participants with hemi-diaphragmatic paresis in each group.
次要结局
- Postoperative pain score at rest (static VAS)(At 1, 3, 6, 12, and 24 hours postoperatively)
- Patient satisfaction(24 hours postoperatively)
研究者
Mahdy Mohamed Elghanam
Assisstant Lecture Menoufia University
Menoufia University