Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) pain score
研究概览
简要总结
This study is a multicenter, randomized (each group was assigned 1:1), double-blind controlled trial.
This study aims to investigate if lidocaine injection into the single-use micro-non-invasive injection cervical dilator (short for disposable cervical dilators) leads to better pain control efficacy compared with normal saline injection in intrauterine device(short for IUD) removal surgery. Furthermore, this study aims to compare cervical dilation degree, safety, and patient satisfaction between groups.
Research objects Between August 1, 2023, and August 1, 2025, 74 healthy women who voluntarily request the removal of the intrauterine device under local anesthesia in Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine.
The subjects will be dividied into two groups at random.
- Trial group: disposable cervical dilator stick combined with lidocaine hydrochloride injection.
- Control group: disposable cervical dilator stick combined with normal saline injection.
Intervention measures:
The nurse fill the syringe with 5ml of either 2% lidocaine hydrochloride injection or normal saline based on the group allocation specified. The appearance of the two drugs is indistinguishable after loading.
The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia. After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance. The nurse connects the disposable cervical dilator to the syringe containing drug. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe direction, and slowly inject drug from the syringe into it within a minute. The researcher waits for another minute before removing the disposable cervical dilator. After that, the researcher tries to insert a number 10 to 4 metal Hegar dilator in sequence, until passes through the internal cervical orifice without resistance.
The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervi. The subject uses VAS to evaluate the degree of pain before, during and after surgery. Oral antibiotics were routinely given post-surgery to prevent infection.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 and <65 years old;
- •Voluntary request for removal of intrauterine device under local anesthesia;
- •No known allergic reactions or sensitivity to lidocaine, physiological saline and polyvinyl formaldehyde polymer materials in the past;
- •Volunteer participation in this study.
排除标准
- •Dysplasia of uterine cavity structure;
- •Known lesions such as uterine fibroids that compress and cause uterine cavity deformation;
- •Presence of untreated acute cervicitis or pelvic inflammatory diseases;
- •History of cervical surgery;
- •Systemic diseases that can affect pain perception;
- •Current or past use of illegal drugs or anesthetic and analgesic drugs;
- •Unable to understand how to score pain using Visual Analog Scale (short for VAS).
研究组 & 干预措施
Trial group
Disposable cervical dilator stick combined with lidocaine hydrochloride injection.
干预措施: Disposable cervical dilator stick combined with lidocaine hydrochloride injection (Procedure)
Control group
Disposable cervical dilator stick combined with normal saline injection.
干预措施: Disposable cervical dilator stick combined with normal saline injection (Procedure)
结局指标
主要结局
Visual analog scale (VAS) pain score
时间窗: 30 minutes after surgery
The subject uses VAS to evaluate the degree of pain 30 minutes after surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Visual analog scale (VAS) pain score
时间窗: Baseline
The subject uses VAS to evaluate the degree of pain before surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
Visual analog scale (VAS) pain score
时间窗: Intraoperative
The subject uses VAS to evaluate the degree of pain at the most painful time during the surgery. Visual analog scale pain score (VAS score), minimum 0mm, maximum 100mm, higher value means more severe pain.
次要结局
- Cervical dilatation(Within one minute after using the disposable cervical dilator)
- Cervical dilatation(Baseline)