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临床试验/NCT06302218
NCT06302218尚未招募4 期

Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement

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: 2024年4月1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
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty

详细描述

Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the surgery's induced stress response, opioid consumption, and opioid-related side effects.

In recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.

This is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 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 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.

排除标准

  • patients who have a history of bleeding diathesis,
  • take anticoagulant therapy,
  • have a History of chronic pain before surgery,
  • have Multiple trauma, cannot assess their pain (dementia),
  • have been operated on under general anaesthesia,
  • have an infection in the area and do not accept the procedure

研究组 & 干预措施

iPACK + ACB

Active Comparator

spinal anesthesia

  • ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)

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

Erectro Spinae Plane Block

Active Comparator

spinal anesthesia

  • ultrasound guided ESPBk - 20ml 0,2% ropivacaine

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

Control group

Placebo Comparator

Only spinal anesthesia - No peripheral nerve block

干预措施: control group (Drug)

结局指标

主要结局

Opioid consumption

时间窗: 48 hours after surgery

Total opiate consumption after surgery

次要结局

  • Time to first rescue opiate analgesia(48 hours after procedure)
  • Numerical Rating Scale [range 0:10](Time Frame: 48 hours after surgery)
  • Neutrophil-to-lymphocyte ratio(48 hours after surgery)
  • Platelet-to-lymphocyte ratio(48 hours after surgery)
  • Quadriceps muscle strength assessed using medical research council scale [range 0:5](Postoperative 24 hours period)

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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