跳至主要内容
临床试验/NCT05671484
NCT05671484已完成不适用

Investigation of the Effects of Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block Applied in Pediatric Infra-umbilical Surgeries on Postoperative Pain and Analgesic Consumption

Namik Kemal University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Total dose of paracetamol consumption

研究概览

简要总结

Regional anesthetic techniques; they reduce postoperative morbidity, provide early mobilization and provide great advantages by significantly reducing the need for narcotic analgesics. Regional anesthetic techniques are widely used in our clinic for postoperative analgesia, especially in infants and children. In patients undergoing lower abdominal surgery, postoperative analgesia is usually provided by systemic opioids and neuraxial methods. Complications such as sedation, respiratory depression, itching, nausea, vomiting and possible paraplegia or bleeding of neuraxial methods due to the use of opioids seem to be the biggest disadvantages of these two methods. Transversalis fascial plane (TFP) block is a regional anesthesia technique that provides intraoperative and postoperative analgesia as an alternative to caudal and epidural analgesia, especially in children. Transversalis fascial plane (TFP) block was first described in 2009. TFP block has been shown to be effective as an alternative to epidural analgesia and as part of a multimodal postoperative analgesic approach in lower abdominal and pelvic surgeries in children. Quadratus lumborum block (QLB) is a widely used regional anesthesia technique. It is used in pediatric patients to reduce postoperative pain in supraumbilical or infraumbilical surgeries. As a common result of all approaches, the main effect in quadratus lumborum block is anesthesia of the lateral cutaneous branches. In our center, the investigators have been using both methods, alone or in combination, routinely for a long time, and the investigators aim to compare the two methods in this study. This study consists of comparing two domain blocks known as part of multimodal analgesia.

详细描述

Transversalis fascial plane block and quadratus lumborum block are performed under general anesthesia just before the surgical incision, unless there are contraindications for the procedure for every patient scheduled for elective infraumbilical surgery in our center. In our study, patients will be divided into 2 groups and the effectiveness of trunk plan blocks, which are part of multimodal analgesia, will be compared. In the first group there will be patients who underwent transversalis fascial plane block (TFPB) alone, and in the second group there will be patients who underwent type III quadratus lumborum block (QLB). Post-operative pain scores with the Face, Leg, Activity, Cry, Consolability (FLACC) score will be recorded in 2-6-12-24th hours. Between both groups, postoperative analgesia need, time of analgesia need, presence of nausea and vomiting, surgeon and parent satisfaction will be followed up and recorded. All patients are operated under general anesthesia. General anesthesia is maintained with inhalation anesthesia. At the end of the surgery, the patient is awakened and taken to the recovery unit. In this prospective randomized study, the investigators will compare the efficacy of these two blocks, which are part of multimodal analgesia, with postoperative analgesic consumption. Postoperative patient comfort, complications, demographic findings will be used as data.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parental acceptation to participate and signed written consent
  • Aged between 3 and 7
  • American Society of Anesthesiologists (ASA) physical score I or II
  • Elective infra umbilical surgery

排除标准

  • Parental refusal to participate
  • Known allergy to local anesthetics
  • American Society of Anesthesiologists (ASA) physical score ≥ III
  • Coagulopathy
  • Hypersensitivity history to the agents to be used
  • Local infections
  • Known anatomically or systemic disorder
  • Known growth and developmental retardation

研究组 & 干预措施

Transversalis Fascial Plane Block Group

Active Comparator

Patients will receive ultrasound-guided transversalis fascial plane block

干预措施: Transversalis Fascial Plane Block (Other)

Quadratus Lumborum Block Group

Active Comparator

Patients will receive ultrasound-guided quadratus lumborum block

干预措施: Quadratus Lumborum Plane Block (Other)

结局指标

主要结局

Total dose of paracetamol consumption

时间窗: in the first 24 hour postoperatively

Total dose of paracetamol consumption in the ward

次要结局

  • FLACC score(in the first 24 hour postoperatively)
  • Number of postoperative nausea and vomiting(in the first 24 hour postoperatively)
  • Parental satisfaction level(in the first 24 hour postoperatively)
  • The 1st time to rescue analgesic need(in the first 24 hour postoperatively)

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Onur Baran

Assistant Professor

Namik Kemal University

研究点 (1)

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