跳至主要内容
临床试验/CTRI/2021/04/032717
CTRI/2021/04/032717已完成不适用

Comparison of Erector Spinae Plane block versus Caudal Epidural block in pediatric patients undergoing lower abdominal surgery under general anesthesia- a randomised study

Dr Zainab Ahmad1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年4月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Duration of post-operative analgesia, defined as time to first request of rescue analgesia ( defined as a FLACC score 4 or verbal request of analgesics from verbal children) at any time from the time of completion of surgery.

研究概览

简要总结

Aim of the study is to compare the effect of Erector Spinae Plane Block with the effect of Caudal Epidural Block in pediatric patients undergoing lower abdominal surgery under general anesthesia. Study will be a single blind randomised study with blinding of outcome assessors and will be conducted in AIIMS Bhopal under the Department of Anesthesiology, and Department of Pediatric Surgery. Both erector spinae plane block and caudal epidural block will be proceeded under the Ultrasound guidance. Primary outcome to be compared will be the duration of post operative analgesia defined as time to first request of rescue analgesia. Randomisation will be done using computer generated random number table and allocation concealment will be done using sequentially numbered opaque sealed envelopes. The study will include all pediatric patient of age 1- 9 years of either sex, ASA(American society of Anesthesiology classification of physical status) grade 1 and 2 undergoing elective and emergency lower abdominal surgeries. Patients having any contraindications to regional technique, any coagulation disorder, local infection around site of block, any anatomical deformity, progressive neurological disorder, any cutaneous anomaly, any hypersensitivity to the local anesthetics or inabilty to identify the landmarks; will be excluded from the study. A standard anesthesia technique will be followed in all the patients included in the study. Well informed written consent will be taken from the patients included in the study. All the records will be confidential, and the patient identity would be known to the chief investigatorand would not be released to anybody else. Participation in the study will be voluntary and refusal to participate will not influence care of the participants in the hospital anyway.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • •The study will include all paediatric patients of age 1 year.
  • •9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower abdominal surgery.

排除标准

  • •·Contraindications to regional technique e.g. allergy to local anesthetic drugs, infection around site of block.
  • •.Any coagulation disorder, sepsis.
  • •·Patient having anatomical deformities & progressive neurological disorder, ·Patient with cutaneous anomalies (angioma, hair tuft, naevus, dimple at the site of block) ·Inability to identify landmarks.
  • •·Patient on enti-epileptic drugs or any other enzyme inducers.
  • •·Hypersensitivity/contra-indication to any of the study drugs.

结局指标

主要结局

Duration of post-operative analgesia, defined as time to first request of rescue analgesia ( defined as a FLACC score 4 or verbal request of analgesics from verbal children) at any time from the time of completion of surgery.

时间窗: Patients will be evaluated at 0, 30 minutes, 1 hours, 2 hours, 6 hours, 12 hours and 24 hours after surgery.

次要结局

  • 1. Intraoperative opioid requirement - number of additional doses of Fentanyl administered intraoperatively.(2. Postoperative pain scale - FLACC score)

研究者

发起方
Dr Zainab Ahmad
申办方类型
Other [Guide for study planned to fulfil requirement of PG thesis (MD Anesthesiology)]

研究点 (1)

Loading locations...

相似试验