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临床试验/NCT06519851
NCT06519851尚未招募不适用

Combined Shoulder Anterior Capsule and Suprascapular Nerve Block Versus Interscalene Block in Shoulder Surgery: Randomized Controlled Clinical Trial

Assiut University0 个研究点目标入组 42 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.

研究概览

简要总结

The study aims to evaluate the postoperative analgesic effect of combined shoulder anterior capsule (SHAC) block with suprascapular nerve block (SSNB) versus Interscalene block (ISB) during the first 24 hours following shoulder surgery.

详细描述

Significant acute postoperative pain is common in adults after shoulder surgery, with approximately 45% reporting severe pain in the immediate postoperative period. This pain may necessitate opioid use for several days. The opioid requirement may be similar to that following gastrectomy or thoracotomy, and opioid-only analgesic techniques for shoulder surgery are commonly associated with opioid-related adverse effects such as nausea , vomiting, respiratory depression, pruritus, allergic reactions, sleep disturbance and constipation.

With the majority of these procedures being performed in the ambulatory setting, providing effective postoperative analgesia has become paramount in promoting quicker recovery and rehabilitation of these patients. Thus, alternative techniques are preferred. Nowadays, several ultrasound guided regional anesthesia methods are used for postoperative analgesia .

The shoulder is formed by two joints the acromioclavicular joint formed by the acromion process of the scapula and the clavicle, and the glenohumeral joint formed by the glenoid process of the scapula and the humeral head.

The shoulder joint is innervated by branches of the brachial plexus which include the suprascapular nerve, the axillary nerve, the subscapularis and lateral pectoral nerves .

The suprascapular nerve arises from the ventral rami of cervical nerve roots (C5 and C6), and it is a branch of the superior trunk of the brachial plexus. The suprascapular nerve is a mixed motor and sensory nerve providing motor innervation to the supraspinatus and infraspinatus muscles. And sensory innervation to the acromioclavicular joint, glenohumeral joint, and ligaments of the shoulder. The axillary nerve also originates from the ventral rami of C5 and C6 and it is a terminal branch of the brachial plexus. The axillary nerve is a mixed motor and sensory nerve providing motor innervation to the deltoid and sensory contributions to the glenohumeral joint . Other nerves involved in the sensory innervation of the shoulder joint include the nerve to subscapularis and the lateral pectoral nerve both of which arise from ventral rami of C5 and C6.

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)

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

入选标准

  • Patients of both genders
  • patients aged 18-65 years
  • BMI of less than 30
  • American Society of Anesthesiologists (ASA) physical status I-II,
  • Patients scheduled for unilateral shoulder surgery under general anesthesia.

排除标准

  • Patient refusal
  • BMI of 30 or more
  • ASA III or more
  • Pregnancy or breast feeding
  • Uncooperative patients with communication difficulties, which might prevent a reliable postoperative assessment.
  • Shoulder revision surgery
  • Pre-existing neurological deficits or neuropathy
  • Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, coagulopathy
  • Patients with chest problems not eligible for ISB

结局指标

主要结局

Evaluation of postoperative analgesia measured by Visual analogue scale during the first 24 hours after shoulder surgery.

时间窗: Pain will be assessed at 1st hour, then at 2, 6, 12, 18 and 24 hours postoperatively using VAS score.

Visual analogue scale consists of a 10 centimeter line, with two end points representing 0 (no pain) and 10 (worst imaginable pain)

次要结局

  • The first time to rescue opioid analgesia, and the total opioid consumption in the first 24 hours postoperatively(24 hours postoperatively)
  • Any Complications related to the blocks(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalia Mohamed Abbas

assisstant lecturer

Assiut University

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