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临床试验/NCT05154318
NCT05154318招募中不适用

Study Comparing the Efficacy of Pericapsular Nerve Group (PENG) Block and Facia Iliaca Compartment Block (FICB) in Hip Fracture - A Prospective Randomised Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月15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
100
试验地点
1
主要终点
Pain score at rest on postoperative day 1

研究概览

简要总结

Hip fracture is a common orthpaedic problem especially in elderly population. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Reviews have shown peripheral nerve blocks including FICB, femoral nerve block and 3-in-1 block could reduce both pain and opioid consumption compared with systematic analgesia. However, there are also literature suggesting that some nerves that account for the major hip joint sensory innervation are not consistently covered. As a result, a new ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018. The primary aim of this study is to compare the analgesic effect of PENG block and FICB in terms of pain score during post-operative period. It also compares the range of movement, quadriceps power and other parameters related to physical functions of the operated hip as secondary outcomes.

详细描述

Hip fracture is a common orthopaedic problem especially in elderly population. The number of hip fractures each year is expected to double from 2.2 million in 2017 to 4.5 million in 2050. It is the commonest reason for elderly to require hospitalisation and emergency operation. Significant morbidities such as pulmonary embolism, pneumonia and bed sore can be resulted from immobility and pain. Hip fracture also contributes to post-operative mortality at a rate about 8% at 1 month and 30% at 1 year.

Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Cochrane review has shown peripheral nerve blocks including FICB, Femoral nerve block and 3-in-1 block could reduce both pain at 30 minute and opioid consumption compared with systemic analgesia. In particular, FICB is found to be superior to opioids for pain control on movement, preoperative analgesic consumption, time to first analgesic request, and time to perform spinal anaesthesia. However, literature suggests that the obturator nerve is not consistently covered.

The anterior hip capsule which contributes the major hip joint sensory innervation is supplied by femoral nerve (FN), obturator nerve (ON) and accessory obturator nerve (AON). As a result, a novel ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018, targeting the above 3 nerves. This is very important as the obturator nerve is also blocked with this technique. Case reports showed reduction in pain scores compared with baseline 30 minutes after block placement and no clinically evident quadriceps weakness was detected.

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, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 18 or above
  • Scheduled for hip fracture corrective surgery in Queen Mary Hospital
  • Chinese patients
  • Able to provide informed oral and written consent
  • Abbreviated Mental Test (AMT) 7 or above

排除标准

  • Patient refusal
  • ASA III or above
  • Allergy to local anaesthetics, opioids, paracetamol, NSAID including COX-2 inhibitors
  • Operation delayed for more than 2 days on admission
  • Pre-existing peripheral neuropathy or history of stroke
  • Preoperative non-walker
  • Pre-existing osteoarthritis of knee (KL grade 4)
  • Multiple fractures (additional to hip fracture)
  • Impaired renal function (Defined as preoperative creatinine level >120 μmol or eGFR <50% of normal reference for their age group
  • Patient with coagulopathy (Platelet < 100 or INR >1.5)
  • Prior surgery at the inguinal or supra-inguinal area

结局指标

主要结局

Pain score at rest on postoperative day 1

时间窗: on postoperative day 1

Measure pain score at rest using numerical rating scale from 0 to 10, where 0 is no pain and 10 is the worst pain

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

Dr. Chan Chi-Wing

Dr

The University of Hong Kong

研究点 (1)

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