Ultrasound-guided Interscalene Block (ISB) Versus Infraspinatus-Teres Minor (ITM) Interfacial Plane Block in Shoulder Arthroscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Efficacy of analgesia
研究概览
简要总结
This study aims to compare the efficacy and safety of ultrasound-guided Interscalene block (ISB) versus Infraspinatus-Teres minor (ITM) interfacial plane block in shoulder arthroscopic surgery.
A prospective, randomized clinical trial will be conducted with 46 patients. Approval was obtained from the Medical Ethics Committee (2022/0126), and written informed consent will be collected from all participants. Patients aged 20-70, ASA I-II, scheduled for arthroscopic shoulder surgery will be divided before the induction of general anesthesia (GA) into two groups:
Group A: will receive the ultrasound guided ISB technique with a 15ml solution of 7.5ml lidocaine 2% and 7.5ml bupivacaine 0.5% be injected between the anterior and middle scalene muscles.
Group B: will receive the ultrasound guided ITM block with the same anesthetic solution be injected between the infraspinatus and teres minor muscles.
Researchers will examine the following outcomes;
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Primary outcome measure: Efficacy of analgesia by Pain score; will be measured by Numerical Rating Scale (NRS) score (0=no pain,1-3=mild,4-6=moderate,7-9=sever,10=most sever) at postoperative 12 hour.
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Secondary outcome measures:
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Duration of analgesia, starting from recovery from general anesthesia (GA) to 1st time giving the patient rescue analgesia ( measured by NRS pain score at 0, 6 ,12, 18 and 24 postoperative hours)
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Risk of complications from techniques
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Patient satisfaction after surgery.
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Rescue analgesic consumption
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Hemodynamics monitoring; measurements of heart rate and mean arterial blood pressure before induction of anesthesia and every 15 minutes during surgery till end of surgery
详细描述
I. Study design:
Randomized comparative study.
II. Study setting and location:
The study will be conducted at the operative room of Souad Kafafi University Hospital (SKUH), Misr University of science and Technology (MUST).
III. Study population:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants, care providers and outcome assessor will be blind regarding the procedure
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 20 to 60,
- •ASA classification I or II,
- •scheduled for arthroscopic shoulder surgery,
- •will be randomized 1:1 into two groups before the induction of general anesthesia (GA)
排除标准
- •Patients who refuse participation.
- •Have allergies to local anesthetics.
- •Phrenic nerve dysfunction.
- •Chronic opioid use.
- •ASA III or higher classification.
- •Coagulopathy.
- •Severe chronic obstructive pulmonary disease.
- •Local infection at the injection site
研究组 & 干预措施
Group A : Ultrasound guided Interscalene block (ISB) technique
Interscalene block (ISB) technique, patients will be place in the supine position and the patient's head facing away from the side to be blocked. The Ultrasound probe will be applied in sterile fashion on the supraclavicular fossa to find the brachial plexus division lateral to the subclavian artery. Then, the probe will be traced cephalad to the C5-C6 root and interscalene muscles at the level of the cricoid cartilage
干预措施: Group A: will receive an ultrasound-guided interscalene block (ISB) (Procedure)
Group B: Ultrasound guided Infraspinatus-teres minor (ITM) interfacial plane block technique
Infraspinatus-teres minor (ITM) interfacial plane block technique, Patients will be placed in the lateral position, and a pillow will be wedged under the anterior shoulder and upper arm. The Ultrasound probe will be applied in sterile fashion and put angled obliquely, to be perpendicular to the direction of muscles to obtain the transverse scan of muscles for the ITM block. After palpation of the posterolateral corner of the acromion, the muscle-tendon units of infraspinatus (IS) and teres minor (Tm) on the humeral head will be identified below the corner. At this time, the probe will be moved slightly caudad to identify the borders of Tm. Once the IS and Tm on the humeral head area identified, by moving the probe medio caudally, the interfascial structure of the IS and Tm could be traced on the posterior surface area of the neck of the scapula.
干预措施: Group B:will receive an ultrasound-guided infraspinatus-teres minor (ITM) interfacial plane block (Procedure)
结局指标
主要结局
Efficacy of analgesia
时间窗: at 12 hours postoperatively
Will be measured by pain score at 12 hours postoperatively using the Numerical Rating Scale (NRS) (0-10; with 0 means no pain and 10 means most intolerable pain)
次要结局
- Complications of the techniques(From time of injection to the end of first 24 hours postoperative)
- Total postoperative morphine consumption (mg)(From recovery from general anesthesia to end of 24hours postoperatively)
- Hemodynamics; mean arterial blood pressure (mmHg)(Before induction of anesthesia and every 15 minutes during surgery till end of surgery)
- Duration of analgesia(Starting from recovery from general anesthesia (GA) to 1st time giving the patient rescue analgesia,)
- Patient satisfaction(for the first postoperative 24 hours)
- Hemodynamics (heart rate)(before induction of anesthesia and every 15 minutes during surgery till end of surgery)
- Total intraoperative analgesic consumption (fentanyl).(During surgery; from induction of anesthesia to end of surgery.)
研究者
Emad Lotfy Mohammed Ahmed
Lecturer of Anesthesia, SICU & Pain management
Misr University for Science and Technology