Transdermal Lidocaine for Pain Control During Hysterosalpingography

NCT ID: NCT04518189

Last Updated: 2020-09-21

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-31

Brief Summary

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the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography

Detailed Description

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hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind randomized trial

Study Groups

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lidocaine patch

5% lidocaine patch applied at 3 hours before the procedure

Group Type EXPERIMENTAL

lidocaine patch

Intervention Type DRUG

lidocaine patch applied 3 hours before the procedure

Sham patch

Sham patch containing no study medication applied 3 hours before the procedure

Group Type PLACEBO_COMPARATOR

Sham patch

Intervention Type DRUG

Sham patch applied 3 hours before the procedure

Interventions

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lidocaine patch

lidocaine patch applied 3 hours before the procedure

Intervention Type DRUG

Sham patch

Sham patch applied 3 hours before the procedure

Intervention Type DRUG

Other Intervention Names

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Experimental Placebo Comparator

Eligibility Criteria

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Inclusion Criteria

* any patient came for Hysterosalpingography

Exclusion Criteria

* any patient has contraindication to Hysterosalpingography
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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 RECRUITING

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

Facility Contacts

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Hany F Sallam, MD

Role: primary

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

01092440504 ext. 002

Other Identifiers

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aswu/295/3/19

Identifier Type: -

Identifier Source: org_study_id

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