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临床试验/NCT05095025
NCT05095025Unknown不适用

PENG Block for Patients Undergoing Neck of Femur (NOF) Fracture Surgery: a Dose Finding Study

University College Cork1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月14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
50
试验地点
1
主要终点
Analgesic success

研究概览

简要总结

The effective dose of local anaesthetic used in PENG blocks to achieve analgesia in patients with fractured neck of femur is unknown. It is planned to address this question using a dixon/massey sequential dosing methodology to establish the ED50 of 0.25% Bupivacaine.

详细描述

Neck of femur (NOF) fracture is a common presentation to the emergency department, particularly in the older population. 77,210 NOF fractures were recorded in the UK and Ireland in 2018 and the number of cases is projected to increase as life expectancy improves. NOF fracture is associated with a high social and economic cost, estimated to cost €45 million annually in Ireland 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. These patients occupied 72,314 acute hospital bed days nationally and 437 of these patients attended CUH. This frail and vulnerable group had an average age of 81 and many people suffered numerous co-morbid conditions. 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. The 30-day mortality for this condition has improved recently. This has likely multifactorial, in part due to the introduction of clinical guidelines, national audits, a focus on processes and changes in how hip fracture care is funded. However, 5% of patients who sustained a hip fracture in Ireland in 2019 died. An additional 4% of patients required new admission to a nursing home following this fracture and a further 13% required convalescent care.

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%. 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.

Regional anaesthesia (RA) has 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 RA in the management of patients with NOF fractures concluded that there was high quality evidence that RA reduces pain on movement within 30 minutes after block placement and reduces opioid consumption and moderate quality evidence that RA reduces the incidence of pneumonia, time to first mobilization and cost.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

The assessor and the patient will be unaware of the dose of bupivacaine administered. The bupivacaine solution will be prepared by an investigator other than those involved in the performance of the PENG block or the assessment of block outcome.

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

  • All patients scheduled for operative repair of hip fracture
  • Patient age 18 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 or otherwise unable to provide consent)
  • Previous RA procedure within 24hours with ongoing analgesia
  • Weight <50kg

研究组 & 干预措施

Bupivacaine dose finding

Experimental

Sequential up and down dose modification based on the outcome of the intervention in the preceding participant

干预措施: Bupivacaine Hydrochloride 20ml injectate (Drug)

结局指标

主要结局

Analgesic success

时间窗: 30 minutes

Verbal rated pain score of ≤3/10 30 minutes after the administration of a predetermined dose of bupivacaine via a continuous PENG catheter

次要结局

  • Analgesic failure(30 minutes)

研究者

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

Brian Declan O'Donnell

Consultant Anaesthesiologist

University College Cork

研究点 (1)

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