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

NCT ID: NCT03298646

Last Updated: 2017-10-02

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

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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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 .

Conditions

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Nulliparity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type DRUG

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

Diclofenac

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

22 women.

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

100 mg Diclofenac oral tablet one hour before the procedure.

Interventions

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Lidocaine Hydrochloride

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

Intervention Type DRUG

Diclofenac

100 mg Diclofenac oral tablet one hour before the procedure.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous cervical surgery.
* Cervical stenosis.
* Known gastritis.
* Recent or active PID.
* Cardiac patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Elsayed Hassan Elbohoty

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams maternity hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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ain shams university

Role: primary

01005646995

ahmed elbohoty

Role: backup

01005646995

Other Identifiers

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Hysteroscopy

Identifier Type: -

Identifier Source: org_study_id