Brief Title
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Official Title
Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Visual analog pain scores immediately after the excision
Secondary Outcome
Visual analog pain scores at the time of anesthetic application
Condition
Uterine Cervical Dysplasia
Intervention
Lidocaine spray
Study Arms / Comparison Groups
Lidocaine spray
Description: 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
101
Start Date
September 2011
Completion Date
December 2012
Primary Completion Date
December 2012
Eligibility Criteria
Inclusion Criteria:
- Any degrees of cervical dysplasia detected from cervical cytology or histology
- Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or
treatment
Exclusion Criteria:
- Allergy to lidocaine
- Pregnancy
- Previous history of cervical operation including conization, LEEP, laser therapy and
cryotherapy
- Cardiac arrhythmia
- Neural disease with impaired sensation
- Lower urinary tract cancer
- Coagulation defect
- Drug dependence
- Lower genital tract infection
- Obvious invasive disease of the cervix
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kittipat Charoenkwan, M.D., ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT01505920
Organization ID
OBG-11-08-15A-12
Responsible Party
Principal Investigator
Study Sponsor
Chiang Mai University
Study Sponsor
Kittipat Charoenkwan, M.D., Principal Investigator, Chiang Mai University
Verification Date
January 2013