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临床试验/NCT06436105
NCT06436105已完成不适用

Comparison of Perioperative Analgesic Effectiveness of Patients Who Had Fasia Iliac Compartment Block and 4in1 Block Applied in Total Knee Prosthesis Surgery

Diskapi Yildirim Beyazit Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年5月30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
60
试验地点
2
主要终点
Total tramadol consumption in 24 hours (mg)

研究概览

简要总结

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

详细描述

Total knee arthroplasty is a surgical procedure performed mostly on patients with osteoarthritis who have failed traditional conservative treatment. Increasing knee osteoarthritis due to reasons such as life expectancy and body mass index causes this surgical procedure to be performed more frequently. The knee joint which is innervated by the femoral, obturator, sciatic nerves and their branches has a complicated innervation and the pain following total knee arthrplasty is quite severe. It is aimed to provide effective analgesia by blocking these nerves or terminal branches with various peripheral nerve blockade methods under USG guidance. In recent years, interest in studies aiming to block these nerves with a single injection has been increasing. 4 in 1 block is a new technique applied from a single injection point to block the saphenous, obturator, sciatic and vastus medialis nerves that innervate the knee joint. Fascia iliaca compartment block is a reliable technique applied from a single injection point to block the femoral, lateral femoral cutaneous and obturator nerves behind the fascia iliaca.

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • With informed consent
  • Elective total knee arthroplasty with spinal anesthesia
  • Oriented and cooperative
  • ASA Classification I-II-III
  • 18-85 years old

排除标准

  • Anticoagulant medication
  • Coagulopathy
  • Infection at the site of peripheral nerve block application
  • Allergy to local anesthetics
  • Pregnant or suspected pregnancy

结局指标

主要结局

Total tramadol consumption in 24 hours (mg)

时间窗: 24 hours postoperatively

Total tramadol consumption used in the first 24 hours postoperatively

次要结局

  • Pain on the Numeric Rating Scale (NRS)(24 hours postoperatively)
  • Rescue Analgesic(24 hours postoperatively)
  • Patient satisfaction(24 hours postoperatively)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Savas Altinsoy

Principal Investigator

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (2)

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