腹横筋膜平面阻滞与腹横肌平面阻滞在小儿术后镇痛中的比较
超声引导下腹横筋膜平面阻滞与腹横肌平面阻滞在小儿腹腔镜手术中镇痛效果的比较
This prospective clinical study aims to compare the postoperative analgesic efficacy of the ultrasound-guided transversalis fascia plane block (TFPB) and the transversus abdominis plane (TAP) block in pediatric patients undergoing laparoscopic surgery. Effective and long-lasting postoperative analgesia is essential for patient and parental satisfaction in pediatric anesthesia. With recent advances in ultrasound technology, regional anesthesia techniques have become increasingly utilized in pediatric practice.
In the TAP block, local anesthetic is injected between the internal oblique and transversus abdominis muscles, providing analgesia typically between Torachal vertebra 10 (T10) and Lumbar vertebra (L1) dermatomes. The transversalis fascia plane block, developed as a modification of this approach, targets the proximal portions of the T12 and L1 nerves by depositing local anesthetic between the transversus abdominis muscle and the transversalis fascia, potentially offering wider sensory coverage.
This study compares both blocks in terms of postoperative pain scores, duration of analgesia, and requirement for rescue analgesics in children undergoing laparoscopic surgery. The results are expected to contribute to the optimization of regional anesthesia techniques and improve pain management strategies in pediatric surgical patients.
研究概览
详细说明
In pediatric anesthesia, achieving effective and long-lasting analgesia is essential for ensuring the satisfaction of both pediatric patients and their parents. To guarantee this, many pediatric anesthesiologists have incorporated various regional anesthesia techniques into their daily clinical practice. Advances in technology have enabled the use of many regional anesthesia techniques across diverse clinical settings.
The transversus abdominis plane (TAP) block is an interfascial plane block technique in which a local anesthetic is typically administered, under ultrasound guidance, between the internal oblique and transversus abdominis muscles. Although several approaches have been described for this block, all involve the injection of anesthetic into this interfascial layer, providing analgesia from the T10 to L1 dermatomes. With the widespread adoption of ultrasound technology in pediatric practice, this technique and related fascial plane blocks have become increasingly popular.
The transversalis fascia plane (TFP) block was developed as a technique aiming to block more thoracic nerves. In this approach, local anesthetic is injected between the transversus abdominis muscle and the deep transversalis fascia at the level of the posterior axillary line, targeting the proximal portions of the T12 and L1 nerves. The blockade extends medially toward the inner surface of the quadratus lumborum muscle, thereby providing a more effective block of the anterolateral abdominal wall.
The aim of this study is to compare the postoperative analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. The primary outcome of the study is the evaluation of postoperative pain using validated pediatric pain assessment scales at defined postoperative intervals. The secondary outcomes include the assessment of additional analgesic requirements, the duration of postoperative analgesia provided by each block, and any block-related complications. Furthermore, this research aims to enhance knowledge regarding regional anesthesia applications in pediatric patients and provide scientific contributions to clinical practice.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Serdivan
-
Sakarya、Serdivan、土耳其（türkiye）、54050
- Sakarya University-Anesthesiology and Reanimation Department
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population will include pediatric patients aged 6 months to 16 years who are scheduled to undergo elective laparoscopic surgery under general anesthesia. All participants will be classified as ASA physical status I or II according to the American Society of Anesthesiologists classification. Patients with ASA III-IV status, known allergy to local anesthetic agents, bleeding diathesis or coagulation disorders, and infection at the injection site will be excluded. Eligible patients of both sexes will be enrolled, and healthy volunteers will not be included. Participants will be randomly assigned to receive either an ultrasound-guided transversalis fascia plane block or a transversus abdominis plane block for postoperative analgesia. The study aims to represent the typical pediatric population undergoing minimally invasive abdominal surgery under general anesthesia.
描述
Inclusion Criteria:
- Pediatric patients aged 6 months to 16 years
- Classified as ASA physical status I or II
- Scheduled to undergo laparoscopic surgery under general anesthesia
Exclusion Criteria:
- Patients classified as ASA physical status III or IV
- Known allergy or hypersensitivity to local anesthetic agents
- Presence of bleeding diathesis or coagulation disorders
- Infection at the injection site or local skin lesions preventing block application
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group Transversalis Fascia Plane Block
Patients in this group will receive an ultrasound-guided transversalis fascia plane block prior to surgery. The local anesthetic will be injected between the transversus abdominis muscle and the deep transversalis fascia at the level of the posterior axillary line, targeting the proximal portions of the T12 and L1 nerves. This technique aims to provide effective analgesia for the anterolateral abdominal wall and to extend sensory blockade coverage compared to traditional Transversus Abdominis Plane block. Postoperative pain, additional analgesic requirements, and duration of analgesia will be monitored and recorded. |
Postoperative analgesia will be assessed using the Visual Analog Scale (VAS) at predefined time points following surgery: 1, 2, 4, 8, 12, and 24 hours postoperatively. Pain evaluation will be performed both at rest and during movement (e.g., coughing or mobilization). Additional analgesics will be administered according to a standardized protocol: intravenous paracetamol (15 mg/kg/dose, every 6 hours as needed) will be given if VAS ≥ 4. Rescue analgesia requirements, including timing and dosage, will be recorded for each patient. The primary aim of this assessment is to compare the analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. Duration of analgesia, postoperative VAS scores, and need for rescue analgesics will be documented to determine the relative effectiveness of each block technique. |
|
Group Transversus Abdominis Plane Block
Patients in this group will receive an ultrasound-guided transversus abdominis plane (TAP) block prior to surgery. The local anesthetic will be administered between the internal oblique and transversus abdominis muscles, typically providing analgesia in the T10-L1 dermatomes. This group will serve as a comparative control to assess the relative efficacy of the TAP block versus the transversalis fascia plane block in managing postoperative pain. Postoperative Visual Analog Scale scores, need for rescue analgesics, and duration of analgesia will be recorded. |
Postoperative analgesia will be assessed using the Visual Analog Scale (VAS) at predefined time points following surgery: 1, 2, 4, 8, 12, and 24 hours postoperatively. Pain evaluation will be performed both at rest and during movement (e.g., coughing or mobilization). Additional analgesics will be administered according to a standardized protocol: intravenous paracetamol (15 mg/kg/dose, every 6 hours as needed) will be given if VAS ≥ 4. Rescue analgesia requirements, including timing and dosage, will be recorded for each patient. The primary aim of this assessment is to compare the analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. Duration of analgesia, postoperative VAS scores, and need for rescue analgesics will be documented to determine the relative effectiveness of each block technique. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Pain Assessment (Visuel Analog Scale)
大体时间：At 1, 2, 4, 8, 12, and 24 hours after surgery.
|
The primary outcome is the comparison of the analgesic efficacy of the transversalis fascia plane block and the transversus abdominis plane block in pediatric laparoscopic surgery, measured using the Visuel Analog Scale (VAS). The Visual Analog Scale is a standardized tool used to quantify the intensity of pain. It consists of a 10-centimeter horizontal line representing a continuous range of pain levels. The minimum score is 0, indicating no pain, and the maximum score is 10, indicating the worst imaginable pain. Higher scores reflect worse outcomes, meaning greater pain intensity. Participants are asked to mark a point on the line that best represents the severity of their pain, and the distance from the zero point is measured in centimeters to obtain the final score. |
At 1, 2, 4, 8, 12, and 24 hours after surgery.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Analgesia
大体时间：24 hours after surgery
|
Time from block administration to the first report of pain Visuel Analog Scale (VAS ≥ 4) or request for rescue analgesia. |
24 hours after surgery
|
|
Rescue Analgesic Requirement
大体时间：24 hours after surgery
|
The number and total dose of additional analgesic medications (Intravenosus paracetamol 15 mg/kg as needed for Visual Analog Scale (VAS) ≥ 4) administered within 24 hours postoperatively. |
24 hours after surgery
|
|
Incidence of Block-Related Complications
大体时间：24 hours after surgery
|
Any block-related adverse events (e.g., hematoma, infection, local anesthetic toxicity) observed perioperatively or postoperatively. |
24 hours after surgery
|
|
Patient and Parental Satisfaction
大体时间：24 hours after surgery
|
Satisfaction with postoperative pain control, assessed using a 5-point Likert scale at 24 hours postoperatively |
24 hours after surgery
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.