Randomized Controlled Trial of the Postoperative Analgesic Efficacy of Ultrasound Guided Intermediate Cervical Plexus Block for Unipolar Sternocleidomastoid Release in Patient With Congenital Muscular Torticollis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain on the FLACC scale
研究概览
简要总结
Congenital Muscular Torticollis (CMT) is a postural deformity of head and neck detected at birth or shortly after birth, primarily resulting from unilateral shortening of Sternocleidomastoid Muscle (SCM). Surgery could be chosen for the treatment for some children, which is accompanied by moderate pain and discomfort. The investigators focused the effectiveness of intermediates cervical plexus block because the dermatome of sensory of cervical plexus block is correlated to that of torticollis. So the effect of analgesia could decrease the use of analgesics.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing general anesthesia for unipolar sternocleidomastoid release in patient with congenital muscular torticollis
排除标准
- •coagulation disorder
- •kidney or liver disease
- •allergy to local anesthetics
研究组 & 干预措施
No block
Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
干预措施: Fentanyl (Drug)
Block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg.
Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
干预措施: intermediate cervical plexus block (Other)
Block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg.
Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
干预措施: Fentanyl (Drug)
Block
ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg.
Fentanyl in postanesthesia care unit(PACU), Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
干预措施: Ibuprofen (Drug)
No block
Fentanyl in PACU, Ibuprofen in ward when pain scale (FLACC) is equal to or more than 4.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Pain on the FLACC scale
时间窗: at 5 min after postanesthesia care unit admission
次要结局
未报告次要终点
研究者
yun jeong chae
Associate Professor
Ajou University School of Medicine