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临床试验/CTRI/2024/01/061043
CTRI/2024/01/061043招募中不适用

INTRAPLEURAL ANALGESIA VS ERECTER SPINAE PLANE BLOCK IN PATIENTS OF BLUNT TRAUMA CHEST - A RANDOMISED CONTROL TRIAL

All India Institute of Medical Science, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
Pain measured by VAS score

研究概览

简要总结

Comparative research with other forms of regional anesthesia (intercostal block) are scarce. The published articles are plagued with small sample size and unclear methodology. No studies have addressed the issue of persistent pain, a common issue following trauma. The blocks/intrapleural injections have typically not been utilized for longer than 24-48 hours in most studies as well. Erector spinae catheter infusion and intermittent intrapleural Ropivacaine injection were not compared in any studies that we could identify. To compare these two approaches in terms of the incidence of long-term pain after 30 days and the control of acute pain during the first 72 to 96 hours, we propose a study. Incidences of pulmonary problems and complications associated with procedures will also be compared.

Primary Objective

ï‚· To compare the analgesic effect (Pain control) of

intermittent intrapleural injection of Ropivacaine, with

erector spinae catheter continuous infusion of Ropivacaine

in blunt trauma chest patients

Secondary Objective(s)

ï‚· To compare the complications related to both technique

ï‚· To assess the long term pain relief & pulmonary

complications

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • All patients with chest trauma and Intercostal chest tube drain in situ.

排除标准

  • Prior involvement in other studies.
  • Known allergy to Ropivacaine or hypersensitivity reaction detected after test dose -Patients who are suffering from Cardiac and respiratory disorders.
  • Patients not able to understand the nature of the study -Patients with bilateral chest trauma,flail chest,patients needing ventilatory support, surgical intervention(thoracotomy),pre-existing pulmonary disease, associated abdominal/brain/spine injury.

结局指标

主要结局

Pain measured by VAS score

时间窗: Pain measured by VAS score 12 hourly till the discharge of patient from hospital.

次要结局

  • -Total rescue analgesics needed postprocedure.(-Complications post procedure.)

研究者

发起方
All India Institute of Medical Science, Bhubaneswar
申办方类型
Government medical college

研究点 (1)

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