NCT01505920

Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial

Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself. Lidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application. An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.

Conditions

• Uterine Cervical Dysplasia

Interventions

Type	Name	Description
PROCEDURE	Lidocaine spray	10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
PROCEDURE	Lidocaine submucosal injection	2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-01-09
• Last updated: 2013-01-15

Locations

1 site across 1 country: Thailand