Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Disposable Cervical Dilator"

Официальное название

Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"

Обзор

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. 1. Trial group: disposable cervical dilator stick combined with lidocaine hydrochloride injection. 2. 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.

Вмешательства

• Процедура Disposable cervical dilator stick combined with lidocaine hydrochloride injection
  The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing lidocaine hydrochloride. The researcher inserts the disposable cervical dilator into the cervical canal in line with
• Процедура Disposable cervical dilator stick combined with normal saline injection
  The subject will undergo routine disinfection and receive cervical paracervical nerve block anesthesia (5mL of 1% lidocaine injection at the level of the bilateral sacral ligaments). After waiting for 2 minutes, the researcher gently checks the depth of the uterine cavity with a probe and then remove it. The nurse connects the disposable cervical dilator to the syringe containing normal saline. The researcher inserts the disposable cervical dilator into the cervical canal in line with the probe

Первичные конечные точки

• Visual analog scale (VAS) pain score [Срок оценки: Baseline]
• Visual analog scale (VAS) pain score [Срок оценки: Intraoperative]
• Visual analog scale (VAS) pain score [Срок оценки: 30 minutes after surgery]

Вторичные конечные точки (2)

• Cervical dilatation [Срок оценки: Baseline]
• Cervical dilatation [Срок оценки: Within one minute after using the disposable cervical dilator]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Hangzhou First People's Hospita — Ханчжоу

Публикации

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• Falcone F, Raimondo G, Stark M, Dessole S, Torella M, Raimondo I. Balloon Catheter for Cervical Priming before Operative Hysteroscopy in Young Women: A Pilot Study. J Invest Surg. 2020 Apr;33(4):301-306. doi: 10.1080/08941939.2018.1503379. Epub 2018 Oct 31. PMID 30380354
• Charoenkwan K, Nantasupha C. Methods of pain control during endometrial biopsy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2020 Jan;46(1):9-30. doi: 10.1111/jog.14152. Epub 2019 Oct 30. PMID 31667985
• Babandi RM, Agboghoroma OC, Durojaiye KW, Jimoh KO, Essiet EA. Pain Relief for Hysterosalpingography: A Randomized Controlled, Double Blinded Trial Comparing Suppository Diclofenac, Prilocaine/Lignocaine (EMLA) Cream And Placebo. West Afr J Med. 2021 Dec 30;38(12):1174-1182. PMID 35035229
• Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4. PMID 27823944
• Veces A, Reyes O. Use of Topical Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Management During Manual Vacuum Aspiration: ADouble-Blind, Randomized, Placebo-Controlled Trial. J Obstet Gynaecol Can. 2019 May;41(5):641-646. doi: 10.1016/j.jogc.2018.05.027. Epub 2018 Oct 26. PMID 31007170
• Wang Y, Chen Q, Liu Z, Chen Y, Zheng Y, Guo J, Zhou F, Lv N, Zhao J, Shen S, Yuan Q, Tong J. Analgesia efficacy of lidocaine transfused by a novel disposable injectable cervical dilator during intrauterine device removal procedure: A randomized clinical trial. Contraception. 2024 Jul;135:110439. doi: 10.1016/j.contraception.2024.110439. Epub 2024 Mar 27. PMID 38552820

Идентификаторы

NCT: NCT05955768 · 2023001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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