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

• Sponsor: Chiang Mai University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01505920
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Dysplasia	Procedure: Lidocaine spray; Procedure: Lidocaine submucosal injection	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine spray 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision	Procedure: Lidocaine spray; 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Active Comparator: 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	Procedure: 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

Outcome Measures

Primary Outcome Measures

1. Visual analog pain scores immediately after the excision [Immediately after the excision]

Secondary Outcome Measures

1. Visual analog pain scores at the time of anesthetic application [At the time of anesthetic application]

2. Visual analog pain scores at 30 minutes after the procedure [At 30 minutes after the procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of OB-GYN, Faculty of Medicine, Chiang Mai University	Chiang Mai		Thailand	50200

Sponsors and Collaborators

• Chiang Mai University

Investigators

• Principal Investigator: Kittipat Charoenkwan, M.D., Chiang Mai University
• Principal Investigator: Asama Vanichtantikul, M.D., Chiang Mai University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kittipat Charoenkwan, M.D., Associate Professor, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT01505920
• Other Study ID Numbers: OBG-11-08-15A-12
• First Posted: Jan 9, 2012
• Last Update Posted: Jan 15, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Uterine Cervical Dysplasia; Cervical Intraepithelial Neoplasia; Lidocaine

Study Results

No Results Posted as of Jan 15, 2013