CTRI/2024/01/062168尚未招募不适用
Effect of perioperative intravenous vitamin B12 on chronic post surgical pain after modified radical mastectomy:A prospective randomiized double blind control study
未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effect of peri operative intra venous vitamin B12 on the incidence of chronic post mastectomypain at 3rd month
研究概览
简要总结
This is a randomised double blind control study conducted in India to evaluate the efficacy of intravenous vitamin B12 500mcg in 500ml normal saline on the day of surgery and on POD1 and 2 on reduction of chronic post surgical pain in patients undergoing modified radical mastectomy.After 3 months of surgery patients are contacted through telephone and pain will be assessed by Numerical Rating Scale(1-10)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with ASA physical status 1,2,3 patients posted for elective modified radical mastectomy.
排除标准
- •patients who are not willing to participate in study patients with pre existing pain syndromes patients with cardiovascular,pulmonary,renal and hepatic disease patients not able to communicate and understand NRS scoring patients with known allergy to study drug pregnant and lactating women.
结局指标
主要结局
To evaluate the effect of peri operative intra venous vitamin B12 on the incidence of chronic post mastectomypain at 3rd month
时间窗: To evaluate the effect of peri operative intra venous vitamin B12 on the incidence of chronic post mastectomypain at 3rd month
次要结局
- To assess the severity of chronic post mastectomy pain using Numerical Rating Scale(NRS)(After 3 months)
研究者
Dr P Hemalatha
Department of Anaesthesiology
研究点 (1)
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