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临床试验/NCT04367818
NCT04367818Unknown不适用

Could Peri-anal Block be Effective as Caudal Block in Trans-anal Pull-through Surgery for Children With Hirschsprung Disease??. A Randomized Controlled Trial.

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Post-operative pain relieve

研究概览

简要总结

IN pediatric patient population pain is considered one of the most misunderstood; under diagnosed and under treated medical problems. If left uncontrolled, pain may have a diverse effect on all aspects of life as it is only a sensory perception but also has emotional, cognitive and behavioral components.

详细描述

Caudal anesthesia is one of the most commonly used regional anesthetic and analgesic technique in pediatric patient as it is an easy safe and reliable method that can be performed for both intraoperative and postoperative analgesia in patient undergoing lower abdominal and lower limb surgery. It can be used for upper abdominal surgery by increasing the volume of local anesthetic injected or through advancing a catheter.

Caudal anesthesia is a common practice given along with general anesthesia to decrease intraoperative inhalational anesthesia requirements, postoperative pain and emergence agitation.

So many patients are complaining from ano-rectal pathologies, these diseases are common in both sexes and all age groups. The spectrum of anorectal disorders ranges from benign and irritating (pruritus- ani) to potentially life-threatening (anorectal cancer) and the surgical intervention is performed mostly under general or regional anesthesia.

While general and regional anesthetics provide reliable anesthesia, they are often associated with nausea,vomiting, urinary retention and motor blockade of lower limbs. Moreover, repeated spinal or epidural punctures performed by inexperienced anesthesiologists often cause delays in the tight schedule of operations.

Several reports have described various forms of local anesthetic infiltration for ano- rectal surgery , hemorrhoidectomy,anal fistula or fissure surgeries or lateral sphincterotomy. Local peri-anal infiltration is a simple procedure that can be easily learned and performed by surgeon and this method allows the operation to begin almost immediately.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes.
  • Patients with age range 3 to 10 years old.
  • Patients with ASA 1 , 2 classification.

排除标准

  • Patient or parents refusal.
  • Allergy to the study drugs.
  • Suspect coagulopathy.
  • Local infection at site of intervention.
  • History of developmental delay.
  • Neuromuscular disorders.
  • Skeletal deformity.

结局指标

主要结局

Post-operative pain relieve

时间窗: 24 hours

Assessment of postoperative pain using FLACC scale and the time to first analgesia request.

次要结局

  • Ramsay's sedation scale(24 hours)
  • Postoperative Complication(24 hours)
  • Postoperative motor power(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Salah Rashed Abd Elraheem

Principal Investigator

Assiut University

研究点 (1)

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