ClinicalTrials.gg
Status unknownNCT03530488Updated May 21, 2018

The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

A Phase 4 interventional study of Lidocaine and Office hystroscopy in Pain During Hystroscopy, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Cairo University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 204 studies testing lidocaine in Pain — 19 open to participants now, 19 under way, 1 of them phase 3. Lidocaine · Pain.

Planned enrollment
14th of 203
250 · median 66
Started
2018
with 8 others
Phase 4
63 of 204
6 open now
Registered
136th of 204
by date
Lead sponsor
5 of 204
Cairo University

Among the 204 studies testing lidocaine in Pain, this one is the 14th largest by planned enrollment of the 203 interventional ones, is one of 9 that started in 2018, is one of 63 in phase 4, and was the 136th registered.

By phase

204 studies; the count open now beside each. This study's row is marked.

No phase79 · 9 open
Phase 4this study63 · 6 open
Phase 322 · 0 open
Phase 217 · 2 open
Phase 2/312 · 1 open
Phase 18 · 0 open
Phase 1/23 · 1 open

By the year they started

First in 2002; this study’s year is marked. 9 started in 2018.

Size and results

Median enrollment 66 across the 203 interventional studies. Of the 157 that completed or were terminated, 66 (42%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 204 studies testing lidocaine in Pain, or all of them as a file.
02

Study summary

women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

Read the detailed description

Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline.

After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

03

Conditions studied

  • Pain During Hystroscopy

Browse trials for

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility

Exclusion criteria

Exclusion Criteria:

  • Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are for office hystroscopy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    Lidocaine group

    intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline 5 minutes before hystroscopy

    Drug: Lidocaine · Procedure: Office hystroscopy

  • Placebo comparator
    control group

    intrauterine and intracervical instillation of 19 ml normal saline 5 minutes before hystroscopy

    Procedure: Office hystroscopy

Interventions

  • intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline

  • ProcedureOffice hystroscopy

    A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

06

What researchers measure

Primary outcomes

  1. Pain assessment during the hysteroscopy

    pain assessment during hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

    Time frame: during hystroscopy procedure

Secondary outcomes

  1. Pain assessment 10 minutes after hysteroscopy

    pain assessment 10 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

    Time frame: 10 minutes after hysteroscopy

  2. Pain assessment 30 minutes after hysteroscopy

    pain assessment 30 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

    Time frame: 30 minutes after hysteroscopy

  3. Pain assessment 60 minutes after hysteroscopy

    pain assessment 60 minutes after hystroscopy using visual analogue scale VAS. is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100

    Time frame: 60 minutes after hysteroscopy

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
08

References and documents

Publications

  • Shoab AY, Maged AM, Ramadan W, Dahab S, Deeb WS, Ali YZA, Mostafa WAI, Hussein EA. The value of endocervical and endometrial lidocaine flushing before office hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):113-117. doi: 10.1002/ijgo.12992. Epub 2019 Oct 19. PubMed 31593299 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03530488
Lead sponsor
Cairo University
Responsible party
Ahmed Maged (professor, Cairo University) — Principal investigator
First posted
May 21, 2018
Start date
May 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
May 21, 2018

Study contacts

Ahmed Maged, MD
Contact
prof.ahmedmaged@gmail.com
+2001005227404
Amira Shoab, MD
Contact
amira_el_sayed_yehia@hotmail.com
+2001005647376
Ahmed Maged
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lidocaine

Start the discussion