Comparison of Interscalene Brachial Plexus Block Versus the Combination of Suprascapular and Infraclavicular Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial With Diaphragmatic Function Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Hemidiaphragmatic Paresis
研究概览
简要总结
This study will compare two regional anesthesia techniques for shoulder surgery and evaluate their effects on diaphragmatic function. The standard regional anesthesia technique for shoulder surgery is the interscalene brachial plexus block (ISB), which provides effective analgesia but is frequently associated with ipsilateral hemidiaphragmatic paresis due to phrenic nerve involvement.
An alternative diaphragm-sparing strategy is the combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB), which may reduce the risk of diaphragmatic dysfunction while maintaining effective analgesia for shoulder surgery.
All participants will receive ultrasound-guided regional anesthesia prior to surgery and will be randomly assigned to one of two groups:
Group 1: Interscalene brachial plexus block Group 2: Suprascapular nerve block combined with infraclavicular brachial plexus block The primary aim of this study is to determine whether the diaphragm-sparing technique reduces the incidence of hemidiaphragmatic paresis while providing analgesia comparable to the standard interscalene block. Diaphragmatic movement will be assessed using ultrasound before and after block placement. Secondary outcomes include postoperative pain intensity, opioid consumption, pulmonary function parameters, and block-related complications.
详细描述
The interscalene brachial plexus block (ISB) is widely used for anesthesia and postoperative analgesia in shoulder surgery because of its reliable and effective pain control. However, ISB is commonly associated with ipsilateral hemidiaphragmatic paresis due to unintended phrenic nerve blockade, which may impair respiratory function, particularly in older patients and in those with pre-existing pulmonary disease.
The combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB) has been proposed as a diaphragm-sparing alternative for shoulder surgery. This approach may provide adequate surgical anesthesia and postoperative analgesia while minimizing the risk of diaphragmatic dysfunction.
This randomized controlled trial will compare the interscalene brachial plexus block with the combined suprascapular and infraclavicular brachial plexus block in patients undergoing elective shoulder surgery. Diaphragmatic function will be evaluated using ultrasound imaging before block performance and after block placement. Additional outcomes will include postoperative pain intensity at rest and during movement, opioid consumption, pulmonary function parameters, block-related complications, length of hospital stay, 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Elective shoulder surgery
- •ASA I-III
- •Planned use of regional anesthesia
- •Signed written informed consent
排除标准
- •Allergy to local anesthetics
- •Planned continuous catheter technique
- •BMI >40 kg/m²
- •Coagulopathy or anticoagulation
- •Pre-existing phrenic nerve palsy
- •Neurological disorder of the operative limb
- •Pregnancy or breastfeeding
- •Participation in another clinical trial within 30 days
研究组 & 干预措施
Interscalene Block (ISB)
Participants will receive a single-shot ultrasound-guided interscalene block using 20 mL of 0.2% ropivacaine.
干预措施: Ropivacaine 0.2% for Interscalene Block (Drug)
Infraclavicular Block (ICB) + Suprascapular Nerve Block (SSNB)
Participants will receive two ultrasound-guided single-shot peripheral nerve blocks:
- Infraclavicular brachial plexus block: 15 mL of 0.2% ropivacaine
- Suprascapular nerve block: 5 mL of 0.2% ropivacaine
All blocks will be performed under ultrasound guidance.
干预措施: Ropivacaine 0.2% for Infraclavicular and Suprascapular Nerve Blocks (Drug)
结局指标
主要结局
Incidence of Hemidiaphragmatic Paresis
时间窗: before block and 30-60 minutes after block.
Incidence of hemidiaphragmatic paresis, defined as a \>75% reduction in diaphragmatic excursion or paradoxical movement on ultrasound M-mode compared with baseline.
次要结局
- Total Opioid Consumption(Within 24 hours after surgery.)
- Pain Scores at Rest (NRS 0-10)(2 hours postoperatively)
- Pain Scores at Rest (NRS 0-10)(6 hours postoperatively)
- Pain Scores at Rest (NRS 0-10)(12 hours postoperatively)
- Pain Scores at Rest (NRS 0-10)(24 hours postoperatively)
- Pain Scores During Movement (NRS 0-10)(48 hours postoperatively)
- Pain Scores at Rest (NRS 0-10)(48 hours postoperatively)
- Pain Scores During Movement (NRS 0-10)(2 hours postoperatively)
- Pain Scores During Movement (NRS 0-10)(6 hours postoperatively)
- Pain Scores During Movement (NRS 0-10)(12 hours postoperatively)
- Pain Scores During Movement (NRS 0-10)(24 hours postoperatively)
- Block-Related Adverse Events(From block placement until 30 days after surgery.)
- Oxygen Saturation (SpO₂)(From block performance until 24 hours after surgery.)
- Respiratory rate (breaths per minute).(From block performance until 24 hours after surgery.)
- Incidence of oxygen desaturation (SpO₂ < 92%)(From block performance until 24 hours after surgery)