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

Phase 3

Completed

• Conditions: Uterine Cervical Dysplasia
• Interventions: Procedure: Lidocaine spray; Procedure: Lidocaine submucosal injection

• Registration Number: NCT01505920
• Lead Sponsor: Chiang Mai University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-13
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine spray	Lidocaine spray	10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Lidocaine submucosal injection	Lidocaine submucosal injection	2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision

Primary Outcome Measures

Name	Time	Method
Visual analog pain scores immediately after the excision	Immediately after the excision

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of OB-GYN, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand