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NCT Number: NCT05955768

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

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.

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Key information

Conditions

Cervical Dilatations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospita

Hangzhou, Zhejiang, 310006, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Disposable cervical dilator stick combined with lidocaine hydrochloride injection

Procedure

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 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. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix.

Disposable cervical dilator stick combined with normal saline injection

Procedure

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 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. The researcher removes the IUD with a ring hook. If necessary, the researcher will use metal Hegar dilators to dilate cervix.

Primary outcomes

  1. Visual analog scale (VAS) pain score

    Time frame: 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.

  2. Visual analog scale (VAS) pain score

    Time frame: 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.

  3. Visual analog scale (VAS) pain score

    Time frame: 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.

Secondary outcomes

  1. Cervical dilatation

    Time frame: Baseline

    Before dilation, 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 records the diameter of the last dilator as the predilated cervical dilation score. The minimum value of cervical dilation is 4, and the maximum value is 10. If the actual dilation of the cervix is not within the measurement range, it is recorded as less than 4 or greater than 10. The larger the value, the greater the degree of cervical dilation.

  2. Cervical dilatation

    Time frame: Within one minute after using the disposable cervical dilator

    Within one minute after using the disposable cervical dilator, 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 records the diameter of the last dilator as the postdilated cervical dilation score. The minimum value of cervical dilation is 4, and the maximum value is 10. If the actual dilation of the cervix is not within the measurement range, it is recorded as less than 4 or greater than 10. The larger the value, the greater the degree of cervical dilation.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 21, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.