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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, M.D., Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01505920
First received: January 5, 2012
Last updated: January 13, 2013
Last verified: January 2013

January 5, 2012
January 13, 2013
September 2011
December 2012   (final data collection date for primary outcome measure)
Visual analog pain scores immediately after the excision [ Time Frame: Immediately after the excision ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01505920 on ClinicalTrials.gov Archive Site
  • Visual analog pain scores at the time of anesthetic application [ Time Frame: At the time of anesthetic application ] [ Designated as safety issue: Yes ]
  • Visual analog pain scores at 30 minutes after the procedure [ Time Frame: At 30 minutes after the procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Uterine Cervical Dysplasia
  • 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
  • Experimental: Lidocaine spray
    10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
    Intervention: Procedure: Lidocaine spray
  • Active Comparator: Lidocaine submucosal injection
    2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision
    Intervention: Procedure: Lidocaine submucosal injection
Vanichtantikul A, Charoenkwan K. Lidocaine spray compared with submucosal injection for reducing pain during loop electrosurgical excision procedure: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):553-7. doi: 10.1097/AOG.0b013e31829d888e.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01505920
OBG-11-08-15A-12
No
Kittipat Charoenkwan, M.D., Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Kittipat Charoenkwan, M.D. Chiang Mai University
Principal Investigator: Asama Vanichtantikul, M.D. Chiang Mai University
Chiang Mai University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP