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临床试验/CTRI/2018/03/012876
CTRI/2018/03/012876招募中不适用

A study to compare postoperative analgesia in patients undergoing modified radical mastectomy under epidural ropivacaine alone or using butorphanol versus fentanyl as adjuvant to ropivacaine

Sri Guru Ram Das Institute Of Medical Sciences And Research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Duration Of Postoperative Analgesia

研究概览

简要总结

The aim of this study is to compare the pain relief and complications after epidural administration of ropivacaine or ropivacaine–butorphenol or ropivacaine-fentanyl or complications arising due to the procedure itself, in patients undergoing Modified Radical Mastectomy(MRM). The study will be conducted on 90 females undergoing Modified Radical Mastectomy will be divided into 3 groups with 30 patients each. Group A will be given ropivacaine 0.25% 6ml with 2 ml of normal saline through epidural route; Group B will receive 6ml of 0.25% ropivacaine with butorphanol 1ml (1mg/ml) and 1 ml normal saline through epidural route.; Group C will receive 6ml of 0.25% ropivacaine with 2 ml fentanyl (100 micrograms) through epidural route. The postoperative analgesia will be given as epidural top-ups in the form of ropivacaine(0.125% 6ml) and the data from the above study will be systematically collected, compiled and statistically analyzed to draw relevant conclusions.

研究设计

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

入排标准

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

入选标准

  • •ASA grade 1 & 2.

排除标准

  • •Patients having bleeding diathesis
  • •Patients on any anticoagulant therapy
  • •Patients with known hypersensitivity to local anaesthetics or study drugs.
  • •Patient suffering from uncontrolled asthma, cardiac, respiratory, renal, thyroid, hepatic and CNS disorders.
  • •Patients with local sepsis or spinal deformity.

结局指标

主要结局

Duration Of Postoperative Analgesia

时间窗: Duration Of Analgesia From Drug Administration To VAS Equals To Or More Than 4 in Postoperative Period In First 24 Hours

次要结局

  • 1.Intraoperative Haemodyanamic Stability(2.Total Dose Of Postoperative Analgesic Requirement)

研究者

发起方
Sri Guru Ram Das Institute Of Medical Sciences And Research
申办方类型
Private medical college

研究点 (1)

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