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临床试验/NCT07240064
NCT07240064已完成不适用

Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block for Analgesia in Pediatric Laparoscopic Abdominal Surgeries: a Prospective, Randomized Comparative Study

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5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
入组人数
50
试验地点
1
主要终点
Time to first analgesic request (hours)

研究概览

简要总结

Laparoscopic abdominal surgeries are frequently performed in pediatric patients and are often associated with significant postoperative pain, which, if inadequately managed, may delay recovery and increase the risk of chronic pain. Optimal analgesia is therefore essential. Regional anesthesia techniques have gained prominence for their ability to provide targeted pain relief, reduce systemic analgesic requirements, and improve recovery outcomes. Among these, the MTAPA through the Perichondral Approach (MTAPA) and the ESPB have attracted attention for potential pediatric use. MTAPA, a refinement of the traditional TAPA, targets thoracoabdominal and lower intercostal nerves, offering effective abdominal wall analgesia. Its perichondral approach aims to enhance local anesthetic spread, potentially improving postoperative pain control. ESPB involves depositing local anesthetic between the erector spinae muscle and vertebral transverse processes, producing analgesia through dorsal and ventral rami blockade. Though widely applied in various surgeries, its role in pediatric laparoscopic abdominal procedures is less studied. MTAPA covers a broader dermatomal range than techniques such as the Transversus Abdominis Plane (TAP) or Oblique Subcostal TAP block, particularly for anterior dermatomes, though most adult reports note coverage between T6-T12. Both MTAPA and ESPB have shown promise in adults, yet their comparative efficacy in pediatric laparoscopic abdominal surgeries remains unclear. This study aims to address this knowledge gap. Therefore, this study aimed to compare the effectiveness of the ESPB and the MTAPA in providing postoperative analgesia for pediatric patients undergoing laparoscopic abdominal surgeries. The study was prospective randomized double blinded comparative and was conducted on 50 patients. They were divided into two equal groups: group (A): they received MTAPA block after induction of GA and group (B): they received ESPB after induction of GA. The study will be double blinded in which the patients, and outcome assessors involved will be blinded to the study allocation and outcomes. Patients received GA induction via propofol 1.5-2.5 mg/kg, fentanyl 1 µg/kg and the maintenance dose were sevoflurane 2%, Tracrium 0.03 mg/kg.

详细描述

This prospective randomized double blinded controlled study was carried out on 50 pediatric patients who scheduled to undergo elective laparoscopic abdominal surgeries admitted to Cairo University Specialized Children Hospital in the duration from …...to…...after the approval of ethical committee. Group M-TAPA (group A) (n=25): Patients received M-TAPA block after induction of GA.

• Group ESPB (group B) (n=25): Patients received ESPB after induction of GA. Patients and outcome assessors were blinded to the group of the patients. A pharmacist who is not involved in the study prepared the interventional medications. Methods

Preoperative assessment:

Medical and surgical history of the patients were taken, clinical examination of the patients was performed and routine laboratory investigations such as CBC, coagulation studies (INR), renal function (serum creatinine) and liver function (SGPT, SGOT) were done. Each patient was instructed about postoperative pain assessment with the Face, Legs, Activity, Cry and Consolability (FLACC) scale. FLACC (0 represents "no pain" while 10 represents "the maximum pain").

Intraoperative:

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Age from 2 to 7 years.
  • •Both sexes.
  • •American Society of Anesthesiologists (ASA) physical status I and II.
  • •Patients undergoing elective laparoscopic abdominal surgeries under general anesthesia.

排除标准

  • •Known allergies to local anesthetics.
  • •Pre-existing chronic pain conditions.
  • •Significant hepatic or renal dysfunction.
  • •Patients with upper airway infection 2 weeks ago.
  • •History of developmental delays, mental retardation, or CNS disease.
  • •Congenital spine anomaly.
  • •Patients with bleeding and coagulation disorders (e.g., platelet count <100,000/mm³, INR > 1.5).
  • •Contraindications to regional anesthesia (

研究组 & 干预措施

Erector spinae plane block

Active Comparator

干预措施: Erector Spinae Plane Block (Procedure)

Modified thoracoabdominal plane block

Active Comparator

干预措施: Modified thoracoabdominal plane block (Procedure)

结局指标

主要结局

Time to first analgesic request (hours)

时间窗: 24 hours

Time to first analgesic request (hours)

次要结局

  • Secondary outcome(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Gbre

doctor mahmoud abdeltawab mahmoud lectrer of anesthesia

Cairo University

研究点 (1)

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