Comparison of the Effectiveness of Interscalene Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total 24-Hour Postoperative Opioid Consumption
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function. Participants are randomized into ISB or SPSIP groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).
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)
盲法说明
The anesthesiologist performing the blocks is aware of the group allocation; all other staff and outcome assessors are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreeing to participate in the study
- •The American Society of Anesthesiologists I-III
- •Scheduled for elective unilateral arthroscopic shoulder surgery
排除标准
- •Refusal to participate in the study
- •Allergy to the medications to be used
- •History of serious heart, kidney or liver disease
- •Neurological deficits or neuropathy
- •History of anticoagulant use
- •Pre-existing operative respiratory dysfunction
- •Having chronic shoulder pain
- •Being about to undergo open surgery
结局指标
主要结局
Total 24-Hour Postoperative Opioid Consumption
时间窗: 0-24 hours postoperatively
Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.
次要结局
- Incidence and Severity of Hemidiaphragmatic Paresis(Pre-block and 30 minutes post-block)
- Duration of Analgesia(Time interval from block completion to initiation of IV PCA fentanyl in each patient)
- Pulmonary Function Changes (FEV1)(Pre-block and 30 minutes post-block)
- Pulmonary Function Changes (FVC)(Pre-block and 30 minutes post-block)
研究者
Omer Doymus
Principal Investigator
Erzurum Regional Training & Research Hospital