Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- pain score after manual vauum aspiration
研究概览
简要总结
This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration
详细描述
This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia
排除标准
- •patient with allergic to lidocaine or history of allergic to lidocaine
- •patient with reproductive and urinary infection
- •patient with abnormal vital sign
- •patient with abnormal kidney and liver function test
研究组 & 干预措施
10% lidocaine spray without adrenaline
4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration
干预措施: 10 % lidocaine spray without adrenaline (Drug)
Placebo
4 puffs of normal saline apply on cervical os before manual vacuum aspiration
干预措施: Placebo (Other)
结局指标
主要结局
pain score after manual vauum aspiration
时间窗: at 30 minutes postoperative
The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain
pain score during manual vauum aspiration
时间窗: during surgery
The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain
次要结局
未报告次要终点
研究者
Metha Songthamwat
Principal investigator
UdonThani Hospital