Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy

Phase 2

• Conditions: Pain Uterus
• Interventions: Drug: Endocervical Lidocaine spray

• Registration Number: NCT03382743
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

Detailed Description

5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study Start: 2017-12-20
• Study First Posted: 2017-12-26
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

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

Inclusion Criteria

Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion Criteria

Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Lidocaine group)	Endocervical Lidocaine spray	5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Procedure time	immediately after the process	from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity
Pain sensation	The VAS will be applied immediately after the procedure ended	The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)

Trial Locations

Locations (2)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt

Kasr Alaini hospital; 🇪🇬 Cairo, Egypt