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

Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955768
Collaborator
(none)
74
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Disposable cervical dilator stick combined with lidocaine hydrochloride injection
  • Procedure: Disposable cervical dilator stick combined with normal saline injection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trial group

Disposable cervical dilator stick combined with lidocaine hydrochloride injection.

Procedure: 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 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.
Placebo Comparator: Control group

Disposable cervical dilator stick combined with normal saline injection.

Procedure: 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 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.

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale (VAS) pain score [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 [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 [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 Outcome Measures

  1. Cervical dilatation [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Age ≥18 and <65 years old;

  2. Voluntary request for removal of intrauterine device under local anesthesia;

  3. No known allergic reactions or sensitivity to lidocaine, physiological saline and polyvinyl formaldehyde polymer materials in the past;

  4. Volunteer participation in this study.

Exclusion Criteria:

  1. Dysplasia of uterine cavity structure;

  2. Known lesions such as uterine fibroids that compress and cause uterine cavity deformation;

  3. Presence of untreated acute cervicitis or pelvic inflammatory diseases;

  4. History of cervical surgery;

  5. Systemic diseases that can affect pain perception;

  6. Current or past use of illegal drugs or anesthetic and analgesic drugs;

  7. Unable to understand how to score pain using Visual Analog Scale (short for VAS).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First People's Hospital of Hangzhou

Investigators

  • Principal Investigator: Yahui Yahui, Yahui, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier:
NCT05955768
Other Study ID Numbers:
  • 2023001
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dilatation, Pathologic
Lidocaine

Study Results

No Results Posted as of Jul 21, 2023