Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Not Applicable

• Conditions: Infertility, Female
• Interventions: Drug: lidocaine patch; Drug: Sham patch

• Registration Number: NCT04518202
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-15
• Last Update Submitted: 2020-08-15
• Study First Posted: 2020-08-19
• Last Update Posted: 2020-08-19
• Study Start: 2020-09-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• patients with an indication for office hysteroscopy

Exclusion Criteria

• patient refuse to participant
• contraindication for lidocaine patch

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine patch	lidocaine patch	5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
Sham patch	Sham patch	Sham patch applied at 6 hours before the scheduled office hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Pain intensity will be assessed by visual analogue scale	10 minutes	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Operative time	15 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt