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NCT04518189 Clinical Trial

Transdermal Lidocaine for Pain Control During Hysterosalpingography

Infertility, Female Clinical Trial

Official title:
Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04518189
Other study ID # aswu/295/3/19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 31, 2021

Study information
Verified date September 2020
Source Aswan University Hospital
Contact hany f Sallam, md
Phone +20102435461
Email hany.farouk@aswu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date August 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- any patient came for Hysterosalpingography

Exclusion Criteria:

- any patient has contraindication to Hysterosalpingography

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lidocaine patch
lidocaine patch applied 3 hours before the procedure
• Sham patch
Sham patch applied 3 hours before the procedure

Locations
Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean pain score during the procedure Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores 10 minutes
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