跳至主要内容
临床试验/CTRI/2023/07/055308
CTRI/2023/07/055308已完成不适用

A study to evaluate the analgesic efficacy of erector spinae plane block with continuous thoracic epidural for patients undergoing thoracotomy surgeries

Aseem Gargava1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月31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
40
试验地点
1
主要终点
percentage decrease in pain using visual analogue scale

研究概览

简要总结

Introduction: Erector spinae plane block is a novel technique of analgesia especially in the thoracic dermatomes. Multiple studies have been done in the past but for sternotomy in cardiac surgeries. Their is a paucity in literature for its analgesic response in thoracotomy and lung surgeries. we thought it would be worthwhile to compare its analgesic efficacy with that of conventional thoracic epidural technique and also to look for any complications or side effects if any.

AIM : To study the analgesic efficacy of erector spinae plane block and continous thoracic epidural analgesia in patients undergoing thoracotomy surgeries

Methodology: patient will be induced using standard general anaesthesia technique followed by administration of erector spinae plane block or thoracic epidural depending upon whichever group the patient is alloted to which will be decided by randomisation using sealed envelope technique. The principal investigator will be administering the block and the assesor will be coinvestigator who will be blinded regarding the procedure. The data will be assessed by a third investigator who is unaware of the group allotment, block administered and the data collected.

Statistical analysis will be done using SPSS of current version. continuous variables will be measured according to appropriate tools of analysis.

Limitations: postoperative pain after 48 hours will not be analysed. Pain during movement or positioning will not be analysed.

Patient requiring prolong ventilation (>48hours) or patient re intubated in first 48 hours will be excluded from the study.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • all patients of above age group posted for thoracotomy surgeries.

排除标准

  • Patient refusal, pregnancy, coagulopathies, seizure disorder, ASA grade III and above, patients on anticoagulants, drug allergy to bupivacaine or history of cardiac or hepatic or renal disorder.

结局指标

主要结局

percentage decrease in pain using visual analogue scale

时间窗: immediate postyoperative period followed by every hourly for next 24 hours

次要结局

  • total rescue analgesic requirement(in first 48 hours (in mg))
  • percentage change in spirometry from baseline(every one hourly in post operative period till 48 hours.)
  • total duration of ventilation(in postoperative period)
  • Total ICU stay(in number of days)

研究者

发起方
Aseem Gargava
申办方类型
Other [self]

研究点 (1)

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