CTRI/2025/03/081861已完成Phase 3 4
Efficacy Of Ropivacaine As A Local Infiltrative Drug On Tonsillectomy Haemorrhage- A Randomized Controlled Trial.
Sulekha Naresh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月6日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Intra-operative bleed
研究概览
简要总结
This study is a randomized controlled trial, single blinded, studying the efficacy of Ropivacaine as local infiltrative drug on tonsillectomy haemorrhage. The study will be done for 18 months and all participants undergoing tonsillectomy will be included and randomised into two groups- Group A and Group B. In Group A, Ropivacaine will be given and in Group B, it will not be used. Outcomes such as intra-operative bleed, post operative haemorrhage, post operative analgesia will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who offered informed written consent/ parental informed written consent to undergo procedure.
- •Patients between the age group of 5 to 30 years Patients with chronic tonsillitis with or without adenoid hypertrophy.
排除标准
- •Patients with acute pharyngeal infection Patients with anemia, systemic hypertension Patients with associated cardiac, hepatic, or haematological diseases.
- •Patients with history of hypersensitivity to amide group of anaesthetic drugs.
结局指标
主要结局
1. Intra-operative bleed
时间窗: 1. Baseline | 2. 24 hours, 48 hours
2. Post tonsillectomy haemorrhage
时间窗: 1. Baseline | 2. 24 hours, 48 hours
次要结局
- Post operative analgesia(6 hours, 24 hours, 48 hours)
研究者
Sulekha Naresh
Post graduate
研究点 (1)
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