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临床试验/NCT06577103
NCT06577103已完成不适用

A Comparative Study Between the Analgesic Effect of Pericapsular Nerve Group Block (PENG) With Lateral Femoral Cutaneous Nerve Block (LFCN) and Pericapsular Nerve Group Block (PENG) With Supra-inguinal Fascia Iliaca Block (SIFIC) in Hip Hemiarthroplasty: a Prospective Randomized Clinical Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Degree of pain

研究概览

简要总结

The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

详细描述

The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids.

The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip.

An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-80 years.
  • Sex: Both sexes.
  • American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
  • Scheduled for hip hemiarthroplasty under general anesthesia.

排除标准

  • Declining to give a written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
  • Psychiatric disorders or narcotic abusers.
  • Significant cognitive dysfunction.
  • American Society of Anesthesiologists (ASA) Physical Status Class IV.
  • Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
  • Opioid abuser patients
  • Pregnancy.

结局指标

主要结局

Degree of pain

时间窗: 24 hours postoperatively

Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.

次要结局

  • Ablility to walk with support within 24 hours(24 hours postoperatively)
  • The total dose of nalbuphine consumption(24 hours postoperatively)
  • The number of patients who needed rescue analgesia(24 hours postoperatively)
  • The ease of giving a sitting position for spinal anesthesia (EOSP)(Intraoperatively)

研究者

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

Moussa Elsayed

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

Ain Shams University

研究点 (2)

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