Transdermal Lidocaine for Pain Control During Hysterosalpingography

Not Applicable

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

• Registration Number: NCT04518189
• Lead Sponsor: Aswan University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-19
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• any patient came for Hysterosalpingography

Exclusion Criteria

• any patient has contraindication to Hysterosalpingography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine patch	lidocaine patch	5% lidocaine patch applied at 3 hours before the procedure
Sham patch	Sham patch	Sham patch containing no study medication applied 3 hours before the procedure

Primary Outcome Measures

Name	Time	Method
Mean pain score during the procedure	10 minutes	Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt