ClinicalTrials.gg
Status unknownNCT03298646Updated Oct 2, 2017

Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy

An interventional study of Lidocaine Hydrochloride and Diclofenac in Nulliparity, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Lidocaine Infusion On Hysteroscopic Media Versus Oral Diclofinac For Pain Relief During Outpatient Hysteroscopy. A Randomized Controlled Trial.

Read the detailed description

10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .

02

Conditions studied

  • Nulliparity
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

  • Age: 18-35 years.
  • 18.5-30 Kg.
  • Nulliparous women assigned for diagnostic hysteroscopy.
  • Informed written consent.

Exclusion criteria

Exclusion Criteria:

  • Previous cervical surgery.
  • Cervical stenosis.
  • Known gastritis.
  • Recent or active PID.
  • Cardiac patients.
Terms in these criteria, in plain language(1)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Lidacaine hydrochloride

    Adding 10 ml of 2% Lidocaine hydrochloride on hysteroscopic saline media during office hysteroscopy to test its efficacy in reducing pain. 22 women.

    Drug: Lidocaine Hydrochloride

  • Active comparator
    Diclofenac

    100 mg Diclofenac oral tablet is administered 1 hour before the procedure to test its efficacy in reducing pain. 22 women.

    Drug: Diclofenac

Interventions

  • 10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.

  • 100 mg Diclofenac oral tablet one hour before the procedure.

06

What researchers measure

Primary outcomes

  1. Pain reduction using Visual Analogue Scale

    Efficacy of lidocaine on saline media and oral diclofenac in reducing pain during office hysteroscopy from start of the procedure till 30 minutes after, using visual analogue scale to assess the severity of pain

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Ain Shams maternity hospital
    Cairo, Egypt
    Recruiting
    • ain shams university · Contactelbohoty79@yahoo.com · 01005646995
    • ahmed elbohoty · Contact01005646995
    • Ahmed E Elbohoty, Ph.D. · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2017; primary completion for Dec 2017, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2017
First posted
Oct 2, 2017
StartEst.
Oct 2017
Primary completionEst.
Dec 2017
CompletionEst.
Jan 2018
Last update
Oct 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03298646
Responsible party
Ahmed Elsayed Hassan Elbohoty (Assistant professor, Ain Shams University) — Principal investigator
First posted
Oct 2, 2017
Start date
Oct 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
Jan 2018 (estimated)
Last update
Oct 2, 2017

Oversight

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 Sep 2017. 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