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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial

NCT03075358

Uterine Bleeding

COMPLETED PHASE3

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration

NCT06344637

Pain, Procedural Lidocaine Obstetric Surgical Procedures

ACTIVE_NOT_RECRUITING NA

1% Lidocaine Paracervical Block for Endometrial Biopsy

NCT06546254

Endometrial Biopsy

RECRUITING NA

Clinical Study on "Pain Control of Cervical Dilation by Lidocaine Solution Injected Into a Disposable Cervical Dilator"

NCT05955768

Cervical Dilatations

ENROLLING_BY_INVITATION NA

Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD

NCT06185933

Pain Satisfaction, Patient

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine spray

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

Group Type EXPERIMENTAL

Lidocaine spray

Intervention Type PROCEDURE

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 to the four quadrant of the cervix, 3 minutes before starting cervical excision

Group Type ACTIVE_COMPARATOR

Lidocaine submucosal injection

Intervention Type PROCEDURE

2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine spray

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No