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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505920
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, M.D., Chiang Mai University

Tracking Information
First Submitted Date  ICMJE January 5, 2012
First Posted Date  ICMJE January 9, 2012
Last Update Posted Date January 15, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
Visual analog pain scores immediately after the excision [ Time Frame: Immediately after the excision ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
  • Visual analog pain scores at the time of anesthetic application [ Time Frame: At the time of anesthetic application ]
  • Visual analog pain scores at 30 minutes after the procedure [ Time Frame: At 30 minutes after the procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Uterine Cervical Dysplasia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2013)
101
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2012)
92
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505920
Other Study ID Numbers  ICMJE OBG-11-08-15A-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kittipat Charoenkwan, M.D., Chiang Mai University
Study Sponsor  ICMJE Chiang Mai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kittipat Charoenkwan, M.D. Chiang Mai University
Principal Investigator: Asama Vanichtantikul, M.D. Chiang Mai University
PRS Account Chiang Mai University
Verification Date January 2013

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