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临床试验/NCT04871061
NCT04871061已完成不适用

Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

Cigli Regional Training Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年5月6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
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Pain scores on the Numeric Rating Scale (NRS)

研究概览

简要总结

The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.

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 (Care Provider, Outcomes Assessor)

盲法说明

Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.

入排标准

年龄范围
35 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hip fracture
  • aged between 35 and 90 years old

排除标准

  • contraindications for spinal anesthesia and PENG block
  • impaired cognition or dementia
  • multiple fractures
  • any previous analgesic administration during the last 12 hours

研究组 & 干预措施

PENG Block

Active Comparator

For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia.

干预措施: PENG Block (Procedure)

Control

Active Comparator

in this group, standardised opioid doses (drug: Fentanyl) will be used for analgesia for positioning pain

干预措施: Conventional opioid analgesia (Fentanyl) (Drug)

结局指标

主要结局

Pain scores on the Numeric Rating Scale (NRS)

时间窗: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)

Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

次要结局

  • Quality of patient's position(Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block))
  • Duration of spinal anesthesia performance(Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block))
  • Analgesic consumption(24 hours)

研究者

发起方
Cigli Regional Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Aygün

principle investigator

Cigli Regional Training Hospital

研究点 (1)

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