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临床试验/NCT06235879
NCT06235879招募中不适用

Comparison Between Ultrasound Guided Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy: Prospective, Randomized Controlled Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
First time for requiring analgesia

研究概览

简要总结

The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy.

详细描述

Shoulder arthroscopy can effectively treat a number of injuries and diseases of the shoulder on an ambulatory basis. Although shoulder arthroscopy is considered minimally invasive, it is related to severe postoperative pain. The use of arthroscopy is popular because it decreases pain, shortens hospital stay, and improves patient satisfaction. However, immediate postoperative pain remains to be a problem in more than 40% of patients.

Regional anesthesia, especially peripheral nerve blocks have various advantages like decreased need for postoperative analgesics, decreased incidence of nausea and vomiting, shortened recovery time and hospital stay, Early ambulation and discharge.

Interscalene brachial plexus (ISB) block is considered the gold standard technique for pain management in shoulder surgery as it provides the most reliable analgesia. However, it has the potential for many complications. The most common of these complications is phrenic nerve palsy, which is reversible but may result in significant respiratory distress especially in patients with compromised respiratory function. Other less common yet serious complications include Horner's syndrome, recurrent laryngeal nerve block that may result in hoarseness of voice, vascular puncture, brachial plexus neuropathy, and unintended injection of local anesthetic into the subarachnoid space, epidural space, or vertebral artery.

Pericapsular nerve group (PENG) block 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.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 60 years old. - Both genders. - BMI ≤35 kg/m
  • American Society of Anesthesiologists Physical Status (ASA-PS) Class I and II. - Patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery.

排除标准

  • Refusal of procedure or participation in the study
  • Patient under age of 18 years old or above 60 years' old
  • Physical status: ASA-PS III or above.
  • Pregnancy or lactation.
  • Infection at site of injection.
  • Psychiatric illness.
  • CNS Diseases like (epilepsy, stroke ...etc.) or neurological disease affecting patient's upper limb.
  • Evidence of coagulopathy or anticoagulation.
  • Patients with respiratory disease, renal or hepatic insufficiency.
  • infection of the skin in the puncture area.
  • Allergy against any of the drugs to be used.
  • Obesity (BMI >35 kg/m2).

结局指标

主要结局

First time for requiring analgesia

时间窗: 24 hours postoperatively

First time for requiring analgesia. It will be defined as the time from recovery until VAS score greater than 3.

次要结局

  • The degree of pain(24 hours postoperatively)
  • Total amount of pethidine consumption in the first 24 hours(24 hours postoperatively)
  • Complications(24 hours postoperatively)

研究者

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

Mohamed Sabry B Mohamed

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt

Ain Shams University

研究点 (2)

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