Comparing the Efficacy of Ultrasound Guided Erector Spinae Plane Block, Ultrasound Guided Caudal Block, and Local Infiltration for Postoperative Pain Control in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair as a Day-Case Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation
研究概览
简要总结
The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus local wound infiltration perioperatively according to:
Primary outcome: to assess and compare the postoperative analgesic effect using pain score:
Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation
Secondary outcomes:
First dose of fentanyl as a rescue analgesia in dose of 0.5 μg/kg. Total doses of fentanyl as a rescue analgesia. Demographic data: age, sex, weight, ASA class. Hemodynamic parameter (MAP in (mm/hg) and heart rate (beats/minute)) Motor function will be assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs.
Assessment of sedation will be done with objective score based on eye opening: 0- spontaneously, 1- on verbal stimulation, 2- on physical stimulation Adverse events: bradycardia, hypotension, respiratory depression, local anesthesia toxicity, subarachnoid injection in caudal block, PONV, agitation, or urinary catheterization.
详细描述
This randomized double-blinded study will be carried out on 75 pediatric patients of both sexes undergoing elective unilateral inguinal hernia surgeries in Tanta University Hospitals for a period of from December 2024 to March 2025.
Informed written consent will be obtained from the parents. They will receive an explanation of the purpose of the study, and every patient will have a secret code number. All data of the patients will be confidential with secret codes and private file for each patient, all given data will be used for the current medical research only.
Any unexpected risks that appeared during the research will be cleared to the participants and ethical committee on time. Investigator who is blinded to group allocation provided postoperative care and assessments. Postoperative pain will be assessed. Motor functions and sedation will be assessed as well.
Inclusion Criteria: pediatric patients of both sexes undergoing elective unilateral inguinal hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Months 至 84 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Inclusion Criteria: pediatric patients of both sexes undergoing elective unilateral inguinal hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.
排除标准
- •Parents refusal. Coagulopathy. Allergy to local anesthesia. Local infection at the site of injection. Neurological anomalies.
- •Exclusion Criteria:
研究组 & 干预措施
Group E
Ultrasound guided erector spinae block
干预措施: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) (Procedure)
Group C
Ultrasound guided caudal block
干预措施: Caudal Block Anesthesia (Procedure)
Group L
Local infiltration of the wound
干预措施: Local infiltration in the wound (Procedure)
结局指标
主要结局
Faces Legs Activity Cry Consolability tool (FLACC, 0- 10) at 15 min, 30 min and 1, 2, 3 and 4 h after operation
时间窗: 4 hours
次要结局
- Analgesic effect of the block(4 hours)
研究者
Mohamed Zakarea Wfa
Assisted professor
Tanta University