Trial Information
Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Visual analog pain scores immediately after the excision
Outcome Time Frame:
Immediately after the excision
Safety Issue:
Yes
Principal Investigator
Kittipat Charoenkwan, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chiang Mai University
Authority:
Thailand: Ethical Committee
Study ID:
OBG-11-08-15A-12
NCT ID:
NCT01505920
Start Date:
September 2011
Completion Date:
December 2012
Related Keywords:
- Uterine Cervical Dysplasia
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia