Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
Primary Purpose
Uterine Cervical Dysplasia
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Lidocaine spray
Lidocaine submucosal injection
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Dysplasia
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
Sites / Locations
- Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lidocaine spray
Lidocaine submucosal injection
Arm Description
10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision
Outcomes
Primary Outcome Measures
Visual analog pain scores immediately after the excision
Secondary Outcome Measures
Visual analog pain scores at the time of anesthetic application
Visual analog pain scores at 30 minutes after the procedure
Full Information
NCT ID
NCT01505920
First Posted
January 5, 2012
Last Updated
January 13, 2013
Sponsor
Chiang Mai University
1. Study Identification
Unique Protocol Identification Number
NCT01505920
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine spray
Arm Type
Experimental
Arm Description
10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Arm Title
Lidocaine submucosal injection
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Lidocaine spray
Intervention Description
10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Intervention Type
Procedure
Intervention Name(s)
Lidocaine submucosal injection
Intervention Description
2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision
Primary Outcome Measure Information:
Title
Visual analog pain scores immediately after the excision
Time Frame
Immediately after the excision
Secondary Outcome Measure Information:
Title
Visual analog pain scores at the time of anesthetic application
Time Frame
At the time of anesthetic application
Title
Visual analog pain scores at 30 minutes after the procedure
Time Frame
At 30 minutes after the procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipat Charoenkwan, M.D.
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asama Vanichtantikul, M.D.
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23921860
Citation
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.
Results Reference
derived
Learn more about this trial
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
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