NCT04085120Unknown不适用
Comparison Between Ropivacaine/Dexamethasone and 10% Lignocaine Injection in Distal Glossopharyngeal Nerve Block for Intractable Cancer Pain- A Randomized Trial
All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain reduction on the basis of the Numeric rating scale (NRS).
研究概览
简要总结
The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more.
- •Pain lasting for at least 2 weeks with an average intensity of 5 or more on an 11-point numeric rating scale (NRS) refractory to a combination strong opioids and NSAIDS
排除标准
- •Local infection or skin ulceration at the puncture site
- •Local anaesthetic allergy
- •Psychiatric illness that affected cooperation.
研究组 & 干预措施
Ropivacaine/dexamethasone group
Experimental
3ml of 0.75% ropivacaine and 1ml of 4mg/l dexamethasone will be injected.
干预措施: 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection (Procedure)
10% lignocaine injection group
Experimental
4 ml of 10% lignocaine
干预措施: 10% lignocaine injection (Procedure)
结局指标
主要结局
Pain reduction on the basis of the Numeric rating scale (NRS).
时间窗: 4 weeks
Pain reduction on the basis of the Numeric rating scale (NRS). From 0 to 10 (No pain to highest pain)
次要结局
- Brief Pain Inventory (BPI)- short form(4 weeks)
- Clinical Global Impression of Change (CGIC)(4 weeks)
- Analgesic requirement and rescue analgesic requirement(4 weeks)
- Patient Global Impression of Change (PGIC)(4 weeeks)
- WHO Quality of Life-BREF(4 weeks)
研究者
Dr.Dinesh Manoharan
Senior Resident
All India Institute of Medical Sciences, New Delhi
研究点 (2)
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