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临床试验/CTRI/2017/01/007714
CTRI/2017/01/007714已完成不适用

An Observational study on Chronic Post Surgical Pain in children undergoing unilateral inguinal hernia surgery

Lady hardinge medical college and associated hospitals1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2014年1月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Incidence of chronic post surgical pain in children aged 2-8 years at 3 months after undergoing unilateral inguinal surgery

研究概览

简要总结

This study is an observational prospective study on chronic postsurgical pain in children undergoing unilateral inguinal hernia surgery. ASAgrade I & II children aged 2-8 years undergoing unilateral inguinal herniasurgeries under general anaesthesia were included in the study population. After pre anaestheticcheckup written informed consent was taken from parents/guardian of the patients.  Anaesthesia was administered the institutional protocols including oral midazolam (0.5mg/kg) administered 30 minutes prior to surgery & surgery was conducted under GAwith any of the three blocks (Caudal, INB, PVB) as per the choice of theconsultant anaesthesiologist. Patients were shifted to the recovery room aftersurgery and acute post operative pain was assessed by observation of FLACC (Face, Legs, Activity, Cry, Consolability) Score at 0, 2, 4, 6, 12 and 24 hours. They were followed up at three months following surgery for assessment of chronic postsurgical pain using revised Bieri’s faces pain scale. Various factors were studied for any association with chronic postsurgical pain including - age, gender, duration of surgery, surgeon’s experience, anaesthetic technique used, and acute postoperative pain.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I & II children aged 2-8 years undergoing unilateral inguinal hernia surgeries under general anaesthesia.

排除标准

  • •Refusal by the parents of the patient.
  • •Patients having allergy to any drug.
  • •Patients with previous surgery at same site.
  • •Patients with any major systemic disease.
  • •Surgery lasting more than 90 minutes.

结局指标

主要结局

Incidence of chronic post surgical pain in children aged 2-8 years at 3 months after undergoing unilateral inguinal surgery

时间窗: 3 months postoperatively

次要结局

  • Incidence of acute postoperative pain in children aged 2-8 years undergoing unilateral inguinal hernia surgery(24 hours postoperatively)
  • Severity and character of chronic postsurgical pain in children aged 2-8years undergoing unilateral inguinal hernia surgery(3 months postoperatively)
  • Factors affecting chronic postsurgical pain(Till 3 months postoperatively)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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