跳至主要内容
临床试验/NCT05002725
NCT05002725Unknown不适用

A Comparison of Quadriceps Muscle Weakness Associated With PENG Blockade or Femoral Nerve Blockade for Patients Undergoing Neck of Femur (NOF) Fracture Surgery

University College Cork1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年1月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
64
试验地点
1
主要终点
Quadriceps Motor Block

研究概览

简要总结

Neck of femur (NOF) fracture is a common presentation to the emergency department, particularly in our older population. NOF fracture is associated with a high social and economic cost with significant effects on patients' quality of life. Analgesia and ambulation are important determinants of outcome following NOF surgery. We propose to compare whether PENG or Femoral Nerve Block is associated with a greater degree of quadriceps motor dysfunction.

详细描述

Neck of femur (NOF) fracture is a common presentation to the emergency department, particularly in our older population.1.NOF fracture is associated with a high social and economic cost with significant effects on patients' quality of life

The latest Irish Hip Fracture Database (IHFD) report from 2019 detailed 3,701 NOF fractures in patients over 60 years of age in Ireland and 437 of these patients attended CUH.2 This frail and vulnerable group had an average age of 81 and many people suffered numerous co-morbid conditions. 3 This population of patients is therefore at significant risk of complications and require multidisciplinary input to optimise clinical outcome

From a patient's perspective, NOF fracture is a very painful condition, requiring early surgical fixation. It is associated with significant morbidity and mortality. In 2019, 5% of patients who sustained a hip fracture in Ireland died, an additional 4% of patients required new admission to a nursing home following this fracture and a further 13% required convalescent care3

These patients are also particularly at risk for under-treatment of pain. Contraindications to many commonly used analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs) exist in this population, including renal dysfunction in 40%5. Older adults suffer more adverse effects from opiate analgesia such as nausea, vomiting, constipation, drowsiness and respiratory complications. This population also have a 25% incidence of cognitive impairment which may make communication and assessment of their pain more challenging. 1, 3 Under-treated pain also confers a 9 fold increased risk of delirium in cognitively intact patients14

Peripheral nerve blocks (PNB) have been extensively researched in this group of patients with a view to improving the quality of pain relief while reducing the side effects of analgesic medications used. In 2017, a Cochrane review on PNB in the management of patients with NOF fractures concluded that there was high quality evidence that PNB reduces pain on movement within 30 minutes after block placement and reduces opioid consumption and moderate quality evidence that PNB reduces the incidence of pneumonia, time to first mobilization and cost. 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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

This will be a double blinded study where patients and assessors are blinded to the technique used. The operator performing the block cannot be blinded. It will not be possible to tell from the appearance of the catheter whether it is a femoral nerve catheter or PENG catheter

入排标准

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

入选标准

  • All patients scheduled for operative repair of hip fracture Patient age 16 years or more ASA I - III

排除标准

  • Patient refusal Coagulopathy Local infection Allergy to Local Anaesthetics Significant cognitive impairment (4AT score>=4) Weight <60kg

研究组 & 干预措施

Femoral Block

Active Comparator

An ultrasound guided Femoral Nerve catheter will be inserted. 20ml of 1.5% lidocaine will be administered.

干预措施: Lidocain (Drug)

PENG

Experimental

An ultrasound guided PENG catheter will be inserted. 20ml of 1.5% lidocaine will be administered.

干预措施: Lidocain (Drug)

结局指标

主要结局

Quadriceps Motor Block

时间窗: 20 mins post procedure

Presence or absence of motor block

次要结局

  • Pain(20 mins post procedure)
  • 12 hr Pain(20 mins post procedure)
  • cumulative opiate consumption(24 hours post op)
  • 24 hr Pain(20 mins post procedure)
  • Quadriceps Motor block(24 hours post op)

研究者

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

Brian Declan O'Donnell

Clinical Senior Lecturer

University College Cork

研究点 (1)

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