Viewing Study NCT01505920


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Study NCT ID: NCT01505920
Status: COMPLETED
Last Update Posted: 2013-01-15
First Post: 2012-01-05
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Sponsor: Chiang Mai University
Organization:

Study Overview

Official Title: Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: