跳至主要内容
临床试验/NCT06600061
NCT06600061已完成不适用

Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy: A Randomized Controlled Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Total morphine consumption

研究概览

简要总结

This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.

详细描述

Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.

Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 6 to 18 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status II, III.
  • Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.

排除标准

  • Allergy to local anesthetics.
  • Severe fixed joint deformity.
  • Previous orthopedic surgery.
  • Patient with abnormal liver/kidney function.
  • Patient with skin damage or infection at the proposed puncture site.

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Rescue analgesia of 0.05 mg/kg morphine will be given if the Wong-Baker score is 4 more to be repeated after 30 min if pain persists until the Wong-Baker score \< 4.

次要结局

  • Time to the 1st rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Patient satisfaction(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (2)

Loading locations...

相似试验