Comparison of Transversus Fascial Plane Block and Anterior Quadratus Lumborum Block for Lower Urogenital Surgery in Pediatric Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
This study aims to compare the analgesic effectiveness of the preoperatively administered Anterior Quadratus Lumborum Block (Anterior QLB) and the Transversalis Fascia Plane Block (TFP block) in children undergoing lower abdominal urogenital surgery. The study will include children aged 6 months to 12 years, with randomization performed using the sealed opaque envelope method, and outcome assessment conducted in a double-blinded manner. All patients will receive a standardized anesthesia protocol, and the regional blocks will be performed under ultrasound (US)-guided techniques.
Perioperative evaluations will include pain levels, hemodynamic responses, additional analgesic requirements, block performance time, technical success rate, and family satisfaction. Postoperative pain will be monitored using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and analgesics will be administered when necessary. By comparing these two commonly used regional anesthesia techniques, this study aims to contribute to improved perioperative pain management strategies in the pediatric population.
详细描述
Regional anesthesia techniques have become increasingly preferred in pediatric anesthesia due to their ability to enhance multimodal analgesia, reduce opioid use and associated side effects, and potentially prevent the development of chronic pain (1). With the widespread adoption of ultrasonography (USG), peripheral nerve blocks have gained popularity as safer alternatives to central neuraxial blocks, which carry a higher complication risk. Truncal blocks have become particularly important in abdominal surgeries. Various quadratus lumborum block (QLB) approaches have demonstrated the ability to provide extensive sensory blockade (T4-L2 dermatomes) in cadaveric and clinical studies. However, because the number of randomized controlled trials in this area remains limited, further research is needed to better establish the efficacy of QLB (2).
The anterior quadratus lumborum block (Anterior QLB) provides effective analgesia for procedures such as inguinal hernia repair and orchiopexy, likely due to its potential spread toward the paravertebral space. The transversalis fascia plane (TFP) block provides analgesia by anesthetizing the ilioinguinal and iliohypogastric nerves as they travel along the ventral surface of the quadratus lumborum muscle and course between the transversalis fascia and the transversus abdominis muscle. These nerves originate from the anterior ramus of the L1 spinal nerve, with contributions from T12.
The primary aim of this study is to compare the effects of the TFP block and the Anterior QLB, performed preoperatively, on perioperative pain levels and analgesic requirements in pediatric patients undergoing lower abdominal urogenital surgery. Secondary aims include evaluating postoperative pain, additional analgesic needs, hemodynamic responses, block performance times, technical success rates, and patient and family satisfaction.
Methods:
Children aged 6 months to 12 years scheduled for inguinal hernia repair or orchiopexy will be enrolled. Exclusion criteria include allergy to local anesthetics, infection at the injection site, coagulopathy or other contraindications to regional anesthesia, inability to obtain informed consent, planned laparoscopic orchiopexy, American Society of Anesthesiologists (ASA) physical status class IV, and anticipated postoperative intensive care requirements.
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 (Participant, Outcomes Assessor)
盲法说明
Participants are blinded to the type of block they receive. The anesthesiologist performing the block is aware of the assignment due to the nature of the intervention. Postoperative pain assessments and data analysis will be conducted by personnel blinded to the treatment groups to minimize bias.
入排标准
- 年龄范围
- 6 Months 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months to 12 years
- •Scheduled for lower abdominal urogenital surgery (e.g., inguinal hernia repair, undescended testis surgery)
- •ASA physical status I-III
- •Parental/guardian informed consent obtained
排除标准
- •Allergy to local anesthetics
- •Infection at the injection site
- •Coagulopathy or other contraindications to regional anesthesia
- •Laparoscopic orchiopexy scheduled
- •ASA physical status IV
- •Inability to obtain consent from parent/guardian
- •Expected need for postoperative intensive care
结局指标
主要结局
Postoperative Pain Score
时间窗: 0, 5, 10, 20, 30, 45, 60 minutes intraoperatively; 2, 4, 8, 12, 24 hours postoperatively
Pain intensity will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at predefined time points. The primary outcome is the difference in perioperative pain levels between the Anterior Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block groups.
次要结局
- Total Analgesic Consumption(First 24 hours postoperatively)
- Time to First Rescue Analgesia(0-24 hours postoperatively)
- Parent/Patient Satisfaction(16th and 24th postoperative hours)
研究者
Münevver Kayhan
Lecturer
Istanbul University - Cerrahpasa
