Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy

NCT ID: NCT03382743

Last Updated: 2018-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2018-03-31

Brief Summary

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lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

Detailed Description

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5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

Conditions

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Pain Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (Lidocaine group)

5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy

Group Type ACTIVE_COMPARATOR

Endocervical Lidocaine spray

Intervention Type DRUG

5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy

Group B (control group)

office hysteroscopy is done without analgesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endocervical Lidocaine spray

5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion Criteria

Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

principal investigator ,lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status RECRUITING

Kasr Alaini hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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sarah M Hassan, Lecturer

Role: primary

01003733671

Sarah M hassan, lecturer

Role: primary

01003733671

Other Identifiers

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171217

Identifier Type: -

Identifier Source: org_study_id

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