CClinicalTrials.gg
Status unknownNCT02640183Updated Dec 28, 2015

EMLA Cream in Hysteroscopy Practice

A Phase 2 interventional study of EMLA and Placebo in Anesthetics, Local, sponsored by Ain Shams Maternity Hospital. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-28.

Sponsored by Ain Shams Maternity Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.

02

Conditions studied

  • Anesthetics, Local
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In context

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients that must perform a diagnostic hysteroscopy.
  2. Acceptance to participate in the study.
  3. Signed informed consent.
  4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
  5. Absence of sedative use 24 h before admission

Exclusion criteria

Exclusion Criteria:

  1. Hypersensitivity or allergy to anesthetics
  2. refusal of the patient
  3. Patients under age 18 and pregnant.
  4. Patients on anti-arrhythmic drugs due to possibility of drug interaction.
  5. Unbearable pain that involves other analgesic measures.
  6. Allergic reactions to topical anesthetics
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (estimated)

Study arms

  • Experimental
    Group A (EMLA)

    3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

    Drug: EMLA

  • Placebo comparator
    Group B (Placebo)

    3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.

    Other: Placebo

Interventions

  • DrugEMLA
  • OtherPlacebo

    Also known as: Ultrasound gel

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What researchers measure

Primary outcomes

  1. Pain experienced during the procedure scored using a VAS.

    All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure. After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed.

    Time frame: Procedure

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02640183
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Hamdy Bakry Mohye Soliman El Kinawy (TA, Ain Shams Maternity Hospital) — Principal investigator
First posted
Dec 28, 2015
Start date
Sep 2015
Primary completion
Mar 2016 (estimated)
Completion
Mar 2016 (estimated)
Last update
Dec 28, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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