NCT07281235已完成不适用
Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.
研究概览
简要总结
The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is:
Which block is more efficient in the perioperative period?
Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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 between 2-7 years old.
- •ASA I-II.
- •Elective surgery under general anaesthesia.
- •Lower abdominal surgery.
排除标准
- •Parent/caregiver refusal.
- •Allergy to one of the study medications.
- •Renal or cardiac disease.
- •Infection or redness at the site of injection.
- •Clinically significant coagulopathy.
- •Spinal anomalies.
- •Altered mental status.
- •Developmental delay.
- •Additional surgery at different surgical sites.
- •Block failure.
结局指标
主要结局
Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.
时间窗: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.
Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia.
次要结局
- Changes to heart rate (beats/minute)(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)
- The time to first rescue analgesic.(from 0 to 8 hours after block administration)
- Total postoperative analgesic requirements.(from 0 to 8 hours after block administration)
- Parent satisfaction with a 5-point Likert scale questionnaire.(At 8 hours after block administration)
- Number of patients required rescue analgesic postoperatively.(From 0 to 8 hours after surgery.)
- Time to Modified Aldrete score ≥9.(from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes))
- Incidence of any adverse effects.(from end of surgery (0 hours) to 8 hours postoperatively)
- Changes to mean arterial pressure (MAP)(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)
- Changes to oxygen saturation(T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery)
研究者
研究点 (1)
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