Clinical trial NCT05955768: Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Disposable Cervical Dilator"
Official title: Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Single-use Micro-non-invasive Injection Cervical Dilator"
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Dilatations
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Visual analog scale (VAS) pain score
timeFrame: Baseline
measure: Visual analog scale (VAS) pain score
timeFrame: Intraoperative
measure: Visual analog scale (VAS) pain score
timeFrame: 30 minutes after surgery
Secondary outcomes:
measure: Cervical dilatation
timeFrame: Baseline
measure: Cervical dilatation
timeFrame: Within one minute after using the disposable cervical dilator
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospita
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Yahui Yahui, Yahui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.