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Completed

NCT Number: NCT01505920

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

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.

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of OB-GYN, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine spray

Procedure

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

Lidocaine submucosal injection

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

Primary outcomes

  1. Visual analog pain scores immediately after the excision

    Time frame: Immediately after the excision

Secondary outcomes

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

    Time frame: At the time of anesthetic application

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

    Time frame: At 30 minutes after the procedure

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2012
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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