Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Narcotic requirement
研究概览
简要总结
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.
详细描述
The study design was a double-blinded randomized controlled trial. A minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and at 6 hour intervals through 24 hours from the time of the block placement.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery
排除标准
- •Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural,
- •there was a preexisting chronic pain disorder,
- •there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments,
- •additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.
结局指标
主要结局
Narcotic requirement
时间窗: 24 hours post intervention
Narcotic requirement was recorded at 24 hours from the time of the block placement.
次要结局
- episodes of nausea/vomiting(24 hours)
- Pain Scores(24 hours post intervention)
- anti-spasmodic requirement(24 hours post intervention)