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临床试验/CTRI/2024/02/063084
CTRI/2024/02/063084尚未招募Phase 3 4

A Randomized Prospective study to see the Efficacy and Safety of KETAMINE added to BUPIVACAINE 0.25% in USG guided Modified Pectoral Block for management of postoperative pain in patients undergoing Modified Radical Mastectomy

Jawahar Lal Nehru Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月8日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
duration of analgesia

研究概览

简要总结

With due approval from institutional ethical committee study will be conducted on 80 female breast carcinoma patients undergoing Modified Radical Mastectomy under General Anaesthesia. A written informed consent will be taken prior to procedure. Participants will be alotted into two groups, Group B will be receiving USG guided infiltration of inj Bupivacaine 0.25% 30ml as Pectoral  Block  and Group BK will be receiving  USG guided infiltration of inj Bupivacaine 0.25% 29ml with inj Ketamine 50mg(1ml) as Pectoral  block  prior to surgery. Participants will be followed in postoperative period for the duration of analgesia, total analegesia  consumption, haemodynamic side effects till patients first complain of pain or demands for analgesia . Data will be recorded and analysed using standard qualitative and quantitative tests , the p value of less than 0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • 1.females undergoing breast cancer surgery.
  • 2.ASA grade I and II.

排除标准

  • 1.Patient refusal.
  • 2.Deranged coagulation profile.
  • 3.History of opioid use or addiction.
  • 4.Obesity 5.Pregnancy.

结局指标

主要结局

duration of analgesia

时间窗: immediate post operation baseline, 30mnts,1hr,2hr,4hr,6hr,12hr,24hr

次要结局

  • 1.Total postoperative analgesic consumption.(2.Haemodynamic variable and side effects)

研究者

发起方
Jawahar Lal Nehru Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr VEENA PATODI

Jawahar Lal Nehru medical college

研究点 (1)

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