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

Chiang Mai University

Status and phase: Completed; Phase 3

Conditions: Uterine Cervical Dysplasia

Treatments: Procedure: Lidocaine submucosal injection; Procedure: Lidocaine spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01505920

OBG-11-08-15A-12

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Lidocaine spray

Experimental group

Description:

10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision

Treatment:

Procedure: Lidocaine spray

Lidocaine submucosal injection

Active Comparator group

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

Treatment:

Procedure: Lidocaine submucosal injection