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临床试验/NCT06236035
NCT06236035已完成不适用

Intraoperative Analgesia Management by Monitoring Analgesia Nociception Index (ANI) in Total Knee Arthroplasty With Femoral Nerve Block: a Randomized Controlled Study

Zonguldak Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
intraoperatively total opioid consumption

研究概览

简要总结

Osteoarthritis of the knee joint is common and total knee arthroplasty (TKA) is performed in patients with advanced joint degeneration, no response to conservative treatments, severe pain and joint instability. Severe pain levels between 4 and 8 in visual analog pain scale (VAS) scores have been reported in the postoperative period. Multimodal analgesia is considered to be the best option for pain control after total knee arthroplasty. Multimodal analgesia is defined as the combined use of different analgesia techniques such as neuraxial analgesia, peripheral nerve blocks, patient-controlled analgesia and different analgesic drugs. For this purpose, peripheral nerve blocks are effectively applied as a component of multimodal analgesia. Thus, side effects such as nausea, vomiting, pruritus and sedation that may occur due to opioid use are reduced. At the same time, in addition to providing effective analgesia, peripheral blocks contribute to early initiation of rehabilitation of the knee joint, early ambulation, reduction of pulmonary complications and early discharge from the hospital.

Recently, objective methods such as skin vasomotor reflex analysis, pupilometry, pulse plethysmographic signals and analgesia nociceptive index (ANI) have been used to standardize the need for intraoperative analgesia in patients under general anesthesia. Among these methods, ANI is a non-invasive method that provides continuous measurement of parasympathetic tone, which is a part of the autonomic nervous system. Electrodes are placed on the chest wall on both sides of the heart and the patient is monitored.

The investigators aimed to compare the analgesia nociception index (ANI) and the conventional method to determine perioperative analgesic needs in patients undergoing total knee arthroplasty under general anesthesia with femoral nerve block.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.18-75 years old, 2.ASA I-II-III risk group 3.undergo knee operation under general anesthesia
  • Patients with preoperative femoral nerve block
  • Patients whose informed consent was read and consent was obtained from them and their guardian

排除标准

  • Those who do not want to participate in the study,
  • ASA IV-V patients
  • Those with central or autonomic nervous system disease

结局指标

主要结局

intraoperatively total opioid consumption

时间窗: during the surgery

total remifentanil consumption during surgery

次要结局

  • pain scores(up to 24 hours after surgery)
  • postoperatif analgesic requirement(up to 24 hours after surgery)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Keziban Bollucuoglu

Principal Investigator

Zonguldak Bulent Ecevit University

研究点 (1)

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