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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine spray | Experimental | 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision |
|
| Lidocaine submucosal injection | Active Comparator | 2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine spray | Procedure | 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog pain scores immediately after the excision | Immediately after the excision |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kittipat Charoenkwan, M.D. | Chiang Mai University | Principal Investigator |
| Asama Vanichtantikul, M.D. | Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of OB-GYN, Faculty of Medicine, Chiang Mai University | Chiang Mai | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23921860 | Derived | 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. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| Lidocaine submucosal injection | Procedure | 2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision |
|
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |