Comparison of Ultrasound-guided Infraspinatus Tubercle Muscle (ITM) Interfascial Block and Interosseous Groove Nerve Block (ISB) for Postoperative Pain Management After Shoulder Arthroscopy: a Randomised, Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Area under the NRS curve at rest during 0-24h postoperatively
研究概览
简要总结
It is proposed to investigate the effectiveness of ultrasound-guided intertrochanteric block of the infraspinatus minor round myofascial block not inferior to the interosseous groove brachial plexus nerve block in postoperative analgesia and overall quality of recovery in shoulder surgery.
详细描述
Intersulcus brachial plexus nerve block is considered to be the best method for pain nerve block after shoulder joint surgery. It can not only effectively reduce the postoperative pain and discomfort of patients, but also reduce the intraoperative demand for opioids. However, the use of intermuscular brachial plexus block should be prohibited when the patient has a clotting disorder or is taking anticoagulant drugs, has a local infection or a systemic infection. There may also be anesthesia risks such as nerve damage, vascular damage, respiratory depression, and diaphragmatic paralysis with dyspnea.
Infraspinatus-teres minor (ITM), first proposed by Shin Hyung Kim, is a single-site injection in the interfascial plane between Infraspinatus and teres minor. Once the IS and Tm on the humeral head area are identified, by moving the probe mediocaudally, the interfascial structure of the IS and Tm can be traced along the glenohumeral joint, scapular neck area. On autopsy, local anesthetics were found to have spread to the suprascapular and axillary nerves. This result suggests that interfascia block injection of local anesthetics between the infraspinatus and teres minor muscles may help relieve pain in the upper shoulder, back, and external sensory areas. At present, there are few clinical reports on the use of infraspinatus-teres minor interfascial block for postoperative analgesia of shoulder joint, and the postoperative analgesia effect is only reported in individual cases, without comparison with other nerve blocks There are few studies on the clinical application of ITM block, but ISB has become the best method for postoperative analgesia of shoulder joint surgery. the investigators designed a prospective, randomized controlled, non-inferior study to investigate the efficacy of ultrasound-guided subaspina-teres minor interfascial block in analgesia and overall quality of recovery after shoulder joint surgery.
The primary outcome indicator was the area under the NRS curve at rest in the 0-24h postoperative period
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)
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
- 是
入选标准
- •Shoulder joint surgery in Jiaxing First Hospital from November 2023 to February 2024;
- •Age 18-80 years old;
- •ASA Grade I-III;
- •The duration of surgery is expected to be 1-3h
排除标准
- •accompanied by nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, Multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, etc.
- •accompanied by abnormal sensory or motor function of the upper limb;
- •Active infection at the puncture site, or coagulation dysfunction (hemophilia, von willeophilia, or International normalized ratio [INR]>2);
- •Patients with severe respiratory diseases and a serious history of cardiovascular and cerebrovascular diseases;
- •ipsilateral shoulder joint surgery history;
- •Patients with nerve block failure;
- •Allergic to local anesthetics;
- •Long-term use of opioids (duration ≥3 months or duration ≥1 month and daily dose ≥5mg morphine equivalent);
- •Operation time <1h or >3h
- •Patients and their families refused surgical anesthesia and were unable to complete the questionnaire.
结局指标
主要结局
Area under the NRS curve at rest during 0-24h postoperatively
时间窗: 0-24 hours after surgery
Anesthesiologists who were not aware of the study subgroups began to assess the analgesic effect of the patients' block at rest using the numeric pain rating scale (NRS) at 0.5h, 3h, 6h, 12h, 18h, and 24h postoperatively.Score range from 0 (no pain) to 10 (worst pain possible).
次要结局
- Complications(during 48 hours after operation)
- Asses The postoperative opioid consumption(24 hours postoperatively)
研究者
Qing-he Zhou
professor
Affiliated Hospital of Jiaxing University