Effect of Intracervical Anesthesia on Pain Associated With the Insertion of Levonorgestrel-releasing Intrauterine System in Nulligravida Women: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain associated with LNG-IUS insertion using VAS
研究概览
简要总结
The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in nulligravida women.
详细描述
No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in reducing pain associated with the tenaculum. It is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following LNG-IUS insertion in nulligravida women.
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)
盲法说明
The care provider will open the randomization envelope and will do one of three possible approaches (a intracervical lidocaine injection, a intracervical dry needling or no intervention). Then, a second care provider will insert the intrauterine contraceptive (IUC) blinding for the approach of the first care provider. After IUC insertion, the latter care provider will assess the pain felt by the woman using proper scales. The woman will be also blinded to the approach used before IUC insertion.
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
- •Age between 18 and 45 years;
- •That were never pregnant before;
- •That wants to use LNG-IUD;
- •Not pregnant at the time of insertion;
- •No haematological disease;
- •That do not have signs and / or symptoms of vaginal / cervical infection.
排除标准
- •Categories 3 and / or 4 for the use of LNG-IUD according to the medical eligibility criteria of the World Health Organization (WHO), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).
研究组 & 干预措施
Anesthesia
A 2% lidocaine without vasoconstrictor injection into the cervix
干预措施: Anesthesia (Drug)
Dry-needling
A placement of thin needle into the cervix without substance injection
干预措施: Dry-needling (Procedure)
结局指标
主要结局
Pain associated with LNG-IUS insertion using VAS
时间窗: Immediately following LNG-IUS insertion
To evaluate pain scores using the visual analog scale (VAS)
次要结局
- Pain associated with LNG-IUS insertion using face scale(Immediately following LNG-IUS insertion)
- Pain associated with tenaculum placement using faces scale(Immediately following tenaculum placement)
- Pain associated with tenaculum placement using VAS(Immediately following tenaculum placement)
- Ease of IUS insertion(Immediately following LNG-IUS insertion)
研究者
Carolina Sales Vieira
MD, PhD
University of Sao Paulo