Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- pain
研究概览
简要总结
Use of long acting reversible contraception (LARC) such as implants or intrauterine contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of being independent of user error and are considered to be underused, especially among young individuals where oral methods have high rates of user failure. IUC is often underused in young or nulliparous women due to fear of pain at insertion.
10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the uterine cavity through a hydrosonography catheter before the tenaculum has been applied but prior to sounding and to insertion of the IUC.
The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a hydrosonography catheter prior to any instrument placement will provide more effective pain relief than instillation of 10 ml placebo (sodium chloride 9mg/ml).
Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group.
Secondary objectives: To evaluate acceptability of the 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age and
- •opting for IUC for contraception
- •with a negative pregnancy test
- •willing to participate in the study after it has been explained orally and in written
排除标准
- •previous conisation,
- •known cervical stenosis,
- •signs of ongoing genital infection,
- •known uterine abnormality,
- •any condition resulting in bleeding disorder or contraindication to any local anestetic will be excluded
研究组 & 干预措施
Mepivacaine
10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter
干预措施: Mepivacaine (Drug)
NaCL
10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter
干预措施: Placebo (Drug)
结局指标
主要结局
pain
时间窗: On day of insertion
difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group.
次要结局
- Acceptability(30 minutes after insertion)
研究者
Helena Kopp Kallner
MD, PhD
Karolinska Institutet