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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, M.D., Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01505920
First received: January 5, 2012
Last updated: January 13, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Uterine Cervical Dysplasia
Procedure: Lidocaine spray
Procedure: Lidocaine submucosal injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Visual analog pain scores immediately after the excision [ Time Frame: Immediately after the excision ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual analog pain scores at the time of anesthetic application [ Time Frame: At the time of anesthetic application ] [ Designated as safety issue: Yes ]
  • Visual analog pain scores at 30 minutes after the procedure [ Time Frame: At 30 minutes after the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 101
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Chiang Mai University

Additional 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
Study First Received: January 5, 2012
Last Updated: January 13, 2013
Health Authority: Thailand: Ethical Committee

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014