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临床试验/NCT05668533
NCT05668533招募中不适用

Comparing Postoperative Analgesic Efficiency of Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Clinical Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
visual analogue scale

研究概览

简要总结

Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. (1) Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain. Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.(2) Regional techniques form an integral part of multimodal analgesia of most of the enhanced recovery protocols and aid in minimizing the requirements of opioids to control acute postoperative pain which results in better, faster recovery and better satisfaction. Also, it is well known that sufficient management of acute pain is essential to prevent its transition to chronic pain.(3) The use of ultrasound guidance and its incorporation into the practice of regional anesthesia has dramatically improved the safety and success of perioperative care.(4) Ultrasound guided regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia. To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.

Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. However, the hemi-diaphragmatic paresis that may occur after the block has led to the search for an alternative to the ISB block. (5) Pericapsular nerve group block (PENG) is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. It was demonstrated that the PENG block may be safely applied for both partial anesthesia and analgesia.(6)

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
Double (Participant, Investigator)

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

  • •ASA physical status class I - II
  • •patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery

排除标准

  • •Patients with respiratory disease, renal or hepatic insufficiency,
  • •infection of the skin in the puncture area,
  • •coagulopathy,
  • •allergy against any of the drugs to be used (bupivacaine),
  • •neuromuscular disease,
  • •obesity (body mass index, BMI >30),
  • •previous analgesic medication, chronic pain, and previously known neurological pathologies or central nervous system disorders

研究组 & 干预措施

1. Interscalene group

Active Comparator

Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).

干预措施: Interscalene versus PENG Block (Diagnostic Test)

2. PENG Block

Active Comparator

Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).

干预措施: Interscalene versus PENG Block (Diagnostic Test)

结局指标

主要结局

visual analogue scale

时间窗: 24 hours postoperative

visual analogue scale to assess the analgesic efficacy of ultrasound-guided intrscalene block versus PENG Block

次要结局

未报告次要终点

研究者

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

rehab zayed

Ass. Professor

Alexandria University

研究点 (1)

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