Comparison of the Effects of Interscalene Block and Superior Trunk Block on Pulmonary Functions for Shoulder Arthroscopic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Rate of Hemidiaphragmatic Paralysis
研究概览
简要总结
The interscalene block (ISB) is one of the peripheral nerve blocks providing surgical anesthesia and postoperative analgesia in shoulder arthroscopy, eliminating the need for general anesthesia. It is performed by administering local anesthetics (LA) to the C5-C6 roots between the scalene muscles at the level of the cricoid cartilage. ISB-related side effects, such as diaphragmatic paralysis, can occur with the spread of LA to the phrenic nerve over the anterior scalene muscle. To prevent this, a superior trunk block (STB) can be performed by administering LA close to the supraclavicular region where the C5-C6 roots merge into the superior trunk (further away from the phrenic nerve). Although there are studies in the literature demonstrating diaphragmatic paralysis using ultrasound and/or spirometry, no study evaluating diaphragmatic paralysis simultaneously with both ultrasound and spirometry under regional anesthesia alone has been found. Therefore, in this study, the investigators aim to assess the effects of this side effect on diaphragmatic excursion using ultrasound simultaneously and on respiratory functions using spirometry.
详细描述
Due to diaphragmatic paralysis, interscalene block (ISB) application is contraindicated in patients with pulmonary issues, leaving general anesthesia as the only option. However, the use of opioids for postoperative analgesia in such patients brings unwanted opioid side effects. Consequently, new approaches have emerged to prevent diaphragmatic paralysis, making peripheral blocks feasible for shoulder arthroscopies in patients with pulmonary problems. This study aims to reassess the hypothesis regarding ISB and superior trunk block (STB), routinely used for shoulder arthroscopy surgery, in patients without pulmonary issues, supported by simultaneous ultrasound measurements of diaphragmatic excursion and spirometry measurements of respiratory function. Additionally, the demographic characteristics of patients, onset time of block effects, postoperative additional analgesic requirements, durations of block effects, and times of initial analgesic needs will be observed and compared.
Research Type Description: The study is prospective randomized research. Respiratory function measurements will be taken from patients undergoing ISB and STB, which are routinely performed in brachial plexus blocks in our clinic. These measurements do not involve any invasive procedures and will be solely quantitatively assessed using ultrasound and respiratory function tests.
Case Report Form: The form that will be used is a case report form. Each participant will be assigned a unique number, and all sections related to the study will be completed for each participant.
Data Collection:
After obtaining consent from patients agreeing to participate in the study, patients will be monitored (blood pressure, heart rate, oxygen saturation), and intravenous access will be established.
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
- Single (Outcomes Assessor)
盲法说明
The investigator who measures the diaphragmatic excursions and spirometric parameters would be blind to the block type performed.
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
- •Patients scheduled for elective shoulder arthroscopic surgery.
- •Age between 18 and 80 years.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Written informed consent obtained.
排除标准
- •Refusal to undergo peripheral nerve block.
- •Pre-existing peripheral nerve disorders.
- •Known respiratory, hepatic, renal, or cardiovascular diseases.
- •Allergy to local anesthetics.
- •Active infection at the block site.
- •Body mass index (BMI) > 40 kg/m².
- •Coagulopathy or current anticoagulant therapy.
- •Sepsis or systemic infection.
- •History of prior surgery at the intended block site.
- •Neurological deficits or psychiatric disorders affecting cooperation.
- •Inability to perform spirometry or comply with study procedures.
研究组 & 干预措施
Interscalene brachial plexus block
Patients who underwent shoulder arthroscopic surgery and recieved interscalene brachial plexus block for anesthesia before surgery
干预措施: Interscalene Nerve Block (Procedure)
Superior trunk brachial plexus block
Patients who underwent shoulder arthroscopic surgery and recieved superior trunk brachial plexus block for anesthesia before surgery
干预措施: Superior trunk block (Procedure)
结局指标
主要结局
Rate of Hemidiaphragmatic Paralysis
时间窗: Baseline (pre-block) and 30 minutes post-block.
Measurement of diaphragmatic excursion (DE) in centimeters using ultrasound during normal and deep breathing. The primary aim is to compare the percentage change in DE between interscalene block (ISB) and superior trunk block (STB) groups. Diagnosis of hemidiaphragmatic paralysis based on diaphragmatic excursion reduction: ≥75% reduction classified as complete paralysis, 25-74% reduction as partial paralysis, and ≤25% reduction as no paralysis.
Rate of Hemidiaphragmatic Paralysis
时间窗: Baseline (pre-block) and 30 minutes post-block.
Measurement of diaphragmatic excursion (DE) in centimeters using ultrasound during normal and deep breathing. The primary aim is to compare the percentage change in DE between interscalene block (ISB) and superior trunk block (STB) groups. Diagnosis of hemidiaphragmatic paralysis based on diaphragmatic excursion reduction: ≥75% reduction classified as complete paralysis, 25-74% reduction as partial paralysis, and ≤25% reduction as no paralysis.
次要结局
- Number of Participants Requiring Additional Analgesics(Intraoperative period and within 24 hours postoperatively.)
- Percentage Change in FEV1/FVC Ratio(Baseline (pre-block) and 30 minutes post-block.)
- Percentage Change in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)(Baseline (pre-block) and 30 minutes post-block.)
- Percentage Change in FEV1/FVC Ratio(Baseline (pre-block) and 30 minutes post-block.)
- Number of Participants Requiring Additional Analgesics(Intraoperative period and within 24 hours postoperatively.)