跳至主要内容
临床试验/CTRI/2022/09/045987
CTRI/2022/09/045987进行中(未招募)2 期

EFFICACY OF ERECTOR SPINAE PLANE BLOCK VS CAUDAL EPIDURAL BLOCK FOR PERIOPERATIVE ANALGESIA IN CHILDREN UNDERGOING OPEN PYELOPLASTY: A RANDOMIZED CONTROLLED STUDY

SIR GANGA RAM HOSPITAL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月10日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Perioperative fentanyl usage (Intraoperative and postoperative fentanyl usage will be

研究概览

简要总结

With the increasing use of ultrasound guided interventions, the erector spinae plane block (ESPB) is slowly gaining popularity for perioperative analgesia in paediatric surgeries. ESPB is a novel interfascial plane block in which a local anaesthetic agent is injected under USG guidance between the Erector spinae muscle and the underlying vertebral transverse processes. In comparison to the popular central neuraxial caudal epidural block (CEB), the ESPB is superficial, and there are no major neurovascular structures in close vicinity of the fascial plane. Applying the ESPB post induction in a surgery like pyeloplasty under GA will thus reduce the chances of neurovascular injury and also decrease the requirements of systemic and opioid analgesics. This will reduce the incidence of respiratory depression, confusion, nausea, vomiting, drowsiness, and prolonged hospital stay etc. seen with opioid use. The proposed randomized controlled study aims to compare the perioperative analgesic efficacy of ESPB vs. CEB in children with PUJ obstruction undergoing pyeloplasty. The study will be carried out among 60 subjects divided into two groups. FLACC score will be measured postoperatively at subsequent time intervals namely at 0 min, 30 min, 1h, 2 h, 3hr, 6 h, 12 h, 18 h and 24 h. Following induction of anaesthesia, Group ESPB will receive an ultrasound guided erector spinae plane block and Group CEB will receive a caudal epidural block. We hypothesize that administration of an ultrasound guided single shot ESPB post induction in an open pyeloplasty operation will be more efficacious for perioperative analgesia and reduce the need for systemic opioids, as compared to a single shot CEB.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Month(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • •Open pyeloplasty
  • •Children between 2 months to 7 years of age.
  • •ASA grade I and II.

排除标准

  • •1.Hypersensitivity to ropivacaine and clonidine
  • •Spine or chest wall deformity
  • •Impaired cardiac, hepatic or neurological function
  • •Patients with coagulative disorders
  • •Parents unwilling to participate
  • •Developmental delay
  • •Undergoing additional surgical procedure at an anatomical location not covered by unilateral ESPB.

结局指标

主要结局

Perioperative fentanyl usage (Intraoperative and postoperative fentanyl usage will be

时间窗: Perioperative period

measured.)

时间窗: Perioperative period

次要结局

  • 1. Time to first rescue analgesia in Post Anaesthesia Care Unit(2. Haemodynamic stability by comparing the haemodynamic parameters (heart rate and)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验