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

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ClinicalTrials.gov Identifier: NCT01505920
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, M.D., Chiang Mai University

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 Type : Interventional  (Clinical Trial)
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 : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


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




Primary Outcome Measures :
  1. Visual analog pain scores immediately after the excision [ Time Frame: Immediately after the excision ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505920


Locations
Thailand
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kittipat Charoenkwan, M.D., Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01505920     History of Changes
Other Study ID Numbers: OBG-11-08-15A-12
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action