Comparison of Interscalene and Infraspinatus-Teres Minor Blocks on Postoperative Opioid Consumption and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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 infraspinatus-teres minor (ITM) blocks 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 ITM groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).
详细描述
This is a single-center, prospective, randomized clinical trial designed to compare the efficacy of Interscalene Brachial Plexus Block (ISB) and Infraspinatus-Teres Minor (ITM) interfascial block in patients undergoing elective unilateral arthroscopic shoulder surgery. The primary objective is to compare total 24-hour postoperative opioid consumption. Secondary objectives include the and pain scores, incidence and severity of hemidiaphragmatic paresis, duration of analgesia (from block completion to initiation of IV PCA), and postoperative pulmonary function changes.
This study aims to determine whether the ITM block provides comparable perioperative analgesia to the ISB block while potentially reducing hemidiaphragmatic paresis and pulmonary compromise.
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
- •The American Society of Anesthesiologists I-III
- •Scheduled for elective unilateral arthroscopic shoulder surgery
- •Provide written informed consent
排除标准
- •Refusal to participate
- •Allergy to study drugs
- •Severe cardiac, renal, or hepatic disease
- •Neurological deficit or neuropathy
- •Anticoagulant therapy
- •Pre-existing respiratory dysfunction
- •Chronic shoulder pain or planned open surgery
研究组 & 干预措施
Interscalene Brachial Plexus Block (ISB)
Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine.
干预措施: Interscalene Brachial Plexus Block (ISB) (Procedure)
Infraspinatus-Teres Minor Block (ITM)
Patients will receive TM block under ultrasound guidance using 25 ml 0.25% bupivacaine between infraspinatus and teres minor muscles.
干预措施: Infraspinatus-Teres Minor Block (ITM) (Procedure)
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(0-24 hours post-block)
- 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
Ali Ahiskalioglu
Principal Investigator Ali Ahıskalıoğlu
Ataturk University