Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- FLACC Score
研究概览
简要总结
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
详细描述
The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.
-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).
Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.
Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.
- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2-12 years.
- •Weight: 15-40 kg.
- •Sex: both males and females.
- •ASA physical status: 1-II.
- •Operation: surgery below umbilicus.
排除标准
- •Allergic reaction to local anesthetics (LAs).
- •Local or systemic infection (risk of meningitis).
- •Coagulopathy.
- •Intracranial hypertension.
- •Hydrocephalus.
- •Intracranial hemorrhage.
- •Parental refusal.
- •Hypovolemia.
- •Spinal deformities, such as spina bifida or myelomeningocele.
- •Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
研究组 & 干预措施
Spinal group
Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
be given by .
干预措施: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% (Drug)
Caudal group
caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
干预措施: caudal plain bupivacaine 2.5mg/kg 0.25% (Drug)
结局指标
主要结局
FLACC Score
时间窗: 24 hours
FLACC scores will be recorded.
次要结局
- Total consumption of rescue analgesics(24 hours)
- Adverse effects(24 hours)
- Postoperative Agitation(60 min.)
- Residual motor paralysis(6 hours)
研究者
Hala Saad Abdel-Ghaffar
Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
Assiut University