跳至主要内容
临床试验/NCT07426939
NCT07426939尚未招募不适用

Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery

Ankara City Hospital Bilkent0 个研究点目标入组 78 人开始时间: 2026年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
78
主要终点
FLACC pain score

研究概览

简要总结

In routine pediatric surgical practice, lower abdominal surgeries are commonly performed. Inadequate control of postoperative pain can hinder functional recovery and may lead to negative behavioral changes as well as parental dissatisfaction. Regional anesthesia techniques are widely recommended for pain management in pediatric surgery, as they reduce the need for parenteral opioids and improve the effectiveness of postoperative pain control, patient comfort, and parental satisfaction.

Various nerve block techniques have been developed to enhance postoperative analgesia and facilitate recovery in pediatric patients. However, there is still no consensus regarding the most effective regional anesthesia strategy for pediatric surgical procedures.

Among regional anesthesia techniques used for pain management in children undergoing lower abdominal surgery, caudal block remains the most commonly applied method. The introduction of real-time ultrasound guidance has improved the reliability and safety of caudal blocks. Nevertheless, a major limitation of this technique is its relatively short duration of action following a single injection, even when long-acting local anesthetics or adjuvant agents are used. Consequently, several fascial plane blocks, such as the quadratus lumborum block, transversus abdominis plane block, and rectus sheath block, have been proposed as alternative approaches for postoperative analgesia in children.

The erector spinae plane block is a regional anesthesia technique that has been applied at thoracic, lumbar, cervical, and sacral levels for both acute and chronic pain management. By providing blockade of both somatic and visceral pain pathways, it has demonstrated effective postoperative analgesic properties in a variety of thoracic and abdominal surgical procedures. The technique involves the injection of a local anesthetic into the interfascial plane between the erector spinae muscle and the transverse process, allowing longitudinal spread of the anesthetic across multiple spinal levels.

With a growing body of evidence supporting its feasibility and effectiveness, the erector spinae plane block has gained increasing attention in pediatric anesthesia practice.

The aim of this study is to evaluate and compare the analgesic efficacy and safety of ultrasound-guided erector spinae plane block and caudal block in pediatric patients undergoing unilateral lower abdominal surgery under general anesthesia. The primary objective is to compare postoperative pain levels between the two techniques using the FLACC score, which assesses facial expression, leg position, activity, crying, and consolability. Secondary objectives include the evaluation of intraoperative heart rate, blood pressure, and oxygen saturation, block application times, parental satisfaction, and the incidence of postoperative side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 to 8 years
  • Scheduled for elective lower abdominal surgery
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Written informed consent obtained from parent(s) or legal guardian(s)

排除标准

  • Presence of anatomical abnormalities
  • Coagulation disorders
  • Infection at the site of block application
  • Severe cardiovascular, neurological, respiratory, or metabolic disease
  • Known allergy to study medications
  • Failed regional block
  • Bilateral surgery or additional surgical procedures involving different surgical sites
  • Refusal of parent(s) or legal guardian(s) to provide consent

结局指标

主要结局

FLACC pain score

时间窗: 0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery

Postoperative pain will be assessed using the FLACC scale. Unit of Measure: Score (0-10)

次要结局

  • Duration of Surgery(Intraoperative period)
  • Block Performance Time(Intraoperative period)
  • Intraoperative Heart Rate(0, 15, 30, 45 minutes and 1 hour after inductio)
  • Duration of Effective Analgesia(Up to 24 hours postoperatively)
  • Duration of Anesthesia(Intraoperative period)
  • Time to first rescue analgesia(Up to 24 hours postoperatively)
  • Intraoperative Mean Arterial Pressure(0, 15, 30, 45 minutes and 1 hour after induction)
  • Intraoperative Oxygen Saturation(0, 15, 30, 45 minutes and 1 hour after induction)
  • Postoperative Adverse Events(First 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

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