Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

NCT ID: NCT04518202

Last Updated: 2020-08-19

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-30

Brief Summary

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To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Detailed Description

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hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blinded randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blinded randomized controlled trial

Study Groups

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lidocaine patch

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Group Type EXPERIMENTAL

lidocaine patch

Intervention Type DRUG

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Sham patch

Sham patch applied at 6 hours before the scheduled office hysteroscopy.

Group Type PLACEBO_COMPARATOR

Sham patch

Intervention Type DRUG

Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

Interventions

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lidocaine patch

5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

Intervention Type DRUG

Sham patch

Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo Comparator

Eligibility Criteria

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Inclusion Criteria

* patients with an indication for office hysteroscopy

Exclusion Criteria

* patient refuse to participant
* contraindication for lidocaine patch
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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hany f Sallam, md

Role: CONTACT

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

+201022336052 ext. 002

Other Identifiers

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aswu/296/3/19

Identifier Type: -

Identifier Source: org_study_id

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