Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy

Pain Uterus Clinical Trial

Official title:

Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03382743
• Other study ID #: 171217
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 19, 2017
• Last updated: January 23, 2018
• Start date: December 20, 2017
• Est. completion date: March 2018

Study information

• Verified date: January 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Uterus

Intervention

Drug:
• Endocervical Lidocaine spray
5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo
Egypt	Kasr El Ainiy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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