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

Study Overview
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Brief Summary
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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.

Official Title
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Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Procedure: Lidocaine spray
* Procedure: Lidocaine submucosal injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine spray<br>10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision | Procedure: Lidocaine spray<br>* 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision<br>|
| Active Comparator: Lidocaine submucosal injection<br>2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision | Procedure: Lidocaine submucosal injection<br>* 2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scores immediately after the excision |  | Immediately after the excision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scores at the time of anesthetic application |  | At the time of anesthetic application | 
| Visual analog pain scores at 30 minutes after the procedure |  | At 30 minutes after the procedure |