Effect of Injectable Intracervical Anesthesia on the Pain Associated With the Insertion of the Levonorgestrel-releasing Intrauterine System in Women Without Previous Vaginal Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery.
H0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments
详细描述
Objective
To evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery. As secondary objectives, the effects of the interventions on the pain scores assessed 2 and 6 hours after the LNG-IUS insertion, the level of discomfort associated with the insertion procedure and the ease of insertion of the LNG-IUS will be evaluated.
Design: open randomized controlled trial Setting: Outpatient contraceptive services Patients: 100 women who want to use the LNG-IUS Interventions: 100 women will be randomized into two groups: a) use of a NSAID (ibuprofen, 400 mg) 1 hour before the LNG-IUS insertion; and b) 2% lidocaine intracervical injection. These women will be evaluated immediately after the LNG-IUS insertion, and then 2 hours and 6 hours after it.
Main outcome measures: Two pain scales will be used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort from the procedure (as rated by the patient). Multivariate logistic regression will be performed to analyze the predictors associated with moderate/severe pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients who wanted to use the LNG-IUS as a contraceptive
- •age between 18 and 45 years
- •nulliparity
- •absence of previous vaginal delivery
排除标准
- •women in categories 3 and/or 4 for LNG-IUS use according to the medical eligibility criteria of the World Health Organization
- •illicit drug and/or alcohol users
- •women with allergies or contraindications to NSAIDs or lidocaine
- •chronic pelvic pain of any etiology
- •abnormalities in the cervix (such as fibrosis or isthmus-cervical incompetence)
- •previous abortion with or without uterine curettage
- •psychiatric disorders
- •continued use of medications that could interfere with the pain threshold
研究组 & 干预措施
intracervical anesthesia
Intracervical anesthesia with lidocaine 2%
干预措施: Intracervical anesthesia with lidocaine 2% (Drug)
ibuprofen
ibuprofen 400 mg
干预措施: ibuprofen 400 mg (Drug)
结局指标
主要结局
Pain
时间窗: immediately after LNG-IUS insertion (approx 1 sec)
Pain associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) insertion (by visual analogue scale and face scale)
次要结局
- Pain(2 and 6 hours after the LNG-IUS insertion)
- Discomfort(immediately after LNG-IUS insertion (approx 1 sec))
- ease of insertion(immediately after LNG-IUS insertion (approx 1 sec))
研究者
Carolina Sales Vieira
Medical Doctor, PhD
University of Sao Paulo