Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Infertility, Female Clinical Trial

Official title:

Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518202
• Other study ID #: aswu/296/3/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with an indication for of?ce hysteroscopy

Exclusion Criteria:

• patient refuse to participant

• contraindication for lidocaine patch

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• lidocaine patch
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
• Sham patch
Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

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	Pain intensity will be assessed by visual analogue scale	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10	10 minutes
Secondary	Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	15 minutes