Evaluation of Postoperative Analgesic Efficacy of Suprainguinal Fascia Iliaca Block Applied With Ultrasonography in Knee Arthroplasty
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
- 2
- 主要终点
- Analgesic consumption
研究概览
简要总结
It was aimed to evaluate the postoperative analgesic efficacy of the suprainguinal fascia iliaca block applied in the postoperative period in terms of 24-hour opioid consumption, pain score, additional analgesic need, and side effects and complications in the postoperative period, and to see the postoperative analgesic effectiveness of this block in patients who underwent knee arthroplasty.
详细描述
Total knee arthroplasty (TKA) is one of the major orthopedic surgeries that cause severe postoperative pain. A successful post-operative outcome is possible with strong and effective pain control followed by early mobilization and a good functional recovery.
There are many studies in the literature showing successful results regarding the effectiveness of suprainguinal fascia iliaca block on postoperative pain in pain control after hip surgery. However, there is not enough information about the use of suprainguinal fascia iliaca block in knee arthroplasty. With this study, the investigators aim to contribute to the literature on the use and effectiveness of suprainguinal fascia iliaca block in knee arthroplasty.
An identification number (ID) number will be randomly assigned to each participants, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, participans will be followed up with these numbers in patient follow-up. Which group the participants will be included in will be determined by the closed envelope method.
Participants who underwent unilateral knee arthroplasty will be included in the prospective and randomized study. The participants will be divided into two groups and suprainguinal fascia iliaca block and patient-controlled analgesia (Group SFI) will be applied to one group and patient-controlled analgesia (Group PCA) will be applied to the other group.
No block attempt will be made to the participants in the patient-controlled analgesia group (Group PCA), and when the patient is taken to the recovery room after surgery, patient-controlled analgesia will be administered and transferred to the ward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.
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
- 否
入选标准
- •Having undergone unilateral knee replacement surgery under elective conditions,
- •Age range of 18-75 years,
- •ASA score I and II,
- •Body mass index < 35kg/m²,
- •written consent who agreed to participate in the study.
排除标准
- •who do not want to be included in the study by not signing the voluntary consent form,
- •Body mass index > 35 kg/m²,
- •Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,
- •Coagulopathy, hepatic or renal failure,
- •Allergic to a local anesthetic agent or one of the drugs used in the study,
- •Having a history of chronic opioid and corticosteroid use,
- •who cannot use the patient-controlled analgesia system and have a psychiatric disease,
- •with operative time less than 20 minutes and more than 120 minutes for better standardization of studies.
结局指标
主要结局
Analgesic consumption
时间窗: Postoperative 24 hours
To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.
次要结局
- Numerical Rating Scale(Postoperative 24 hours)
研究者
Hale Kefeli Celik
Anesthesiologist, Principal Investigator
Samsun Education and Research Hospital