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

Uterine Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505920
• Other study ID #: OBG-11-08-15A-12
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2012
• Last updated: January 13, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain scores immediately after the excision		Immediately after the excision	Yes
Secondary	Visual analog pain scores at the time of anesthetic application		At the time of anesthetic application	Yes
Secondary	Visual analog pain scores at 30 minutes after the procedure		At 30 minutes after the procedure	Yes