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临床试验/NCT07023107
NCT07023107已完成4 期

Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Neutrophil-to-lymphocyte ratio

研究概览

简要总结

Effect of PENG block on NLR and PLR following hip arthroplasty

详细描述

The NLR is a sensitive indicator of inflammation confirmed in numerous studies and has a predictive and prognostic value. NLR is a cheap, simple, fast-acting, readily available stress and inflammation parameter with high sensitivity and low specificity. Dynamic changes in the NLR precede the clinical state by several hours and may alert clinicians to the ongoing pathological process early. NLR is a new promising marker of cellular immune activation, an important indicator of stress and systemic inflammation. It opens a new dimension for clinical medicine, enabling a better understanding of the biology of inflammation, the linkage and antagonism between innate and adaptive immunity, and their clinical consequences for health and disease.

NLR is affected not only by surgical trauma but also by the method of anesthesia. In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. However, there have been very few studies evaluating the effect of various methods of anesthesia on the NLR.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ASA classification I-III
  • Aged 60-100 years
  • Who will be scheduled for hip arthroplasty under spinal anesthesia

排除标准

  • Patients who have a history of bleeding diathesis
  • Take anticoagulant therapy
  • History of chronic pain before surgery
  • Multiple trauma
  • patients unable to assess their pain (dementia)
  • patients operated under general anesthesia
  • patients having an infection in the region of the procedure
  • the patient who does not accept the procedure

研究组 & 干预措施

Sham blocks

Placebo Comparator

PENG block with 20ml of 0.9% sodium chloride

干预措施: 0.9% Sodium Chloride Injection (Drug)

PENG block

Active Comparator

PENG block with 20ml 0f 0.2% ropivacaine

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

结局指标

主要结局

Neutrophil-to-lymphocyte ratio

时间窗: 12 hours after surgery

Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample, but sometimes also from cells that infiltrate tissue, such as tumor.

次要结局

  • PLR(48 hours after surgery)
  • NLR(48 hours after surgery)
  • first need of opiate(48 hours after procedure)
  • Opioid Consumption(48 hours after surgery)
  • Pain score(24 hours after surgery)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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