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

NCT01505920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-01-15

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Dysplasia

Interventions

PROCEDURE

Lidocaine spray

10% lidocaine spray 40 mg applied directly to 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

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Principal Investigators

  • Kittipat Charoenkwan, M.D. · Chiang Mai University

  • Asama Vanichtantikul, M.D. · Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505920 on ClinicalTrials.gov