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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505920

Enrollment

101

Registered

2012-01-09

Start date

2011-09-30

Completion date

2012-12-31

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Dysplasia

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.

Interventions

PROCEDURELidocaine spray

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

PROCEDURELidocaine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Visual analog pain scores immediately after the excision	Immediately after the excision

Secondary

Measure	Time frame
Visual analog pain scores at 30 minutes after the procedure	At 30 minutes after the procedure
Visual analog pain scores at the time of anesthetic application	At the time of anesthetic application

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026