Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine spray | Procedure | — | UNRESOLVED |
| Lidocaine submucosal injection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lidocaine spray
- description
- 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
- interventionNames
- Procedure: Lidocaine spray
- type
- ACTIVE_COMPARATOR
- label
- Lidocaine submucosal injection
- 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
- interventionNames
- Procedure: Lidocaine submucosal injection
Primary outcomes (1)
- measure
- Visual analog pain scores immediately after the excision
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVanichtantikul 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. PMID 23921860