Intraoperative Analgesia Management by Monitoring Analgesia Nociception Index (ANI) in Total Knee Arthroplasty With Femoral Nerve Block: a Randomized Controlled Study
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
- 是
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
Keziban Bollucuoglu
Principal Investigator
Zonguldak Bulent Ecevit University
