NCT01505920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

January 5, 2012

Last Update Submit

January 13, 2013

Conditions

Uterine Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Visual analog pain scores immediately after the excision

    Immediately after the excision

Secondary Outcomes (2)

  • Visual analog pain scores at the time of anesthetic application

    At the time of anesthetic application

  • Visual analog pain scores at 30 minutes after the procedure

    At 30 minutes after the procedure

Study Arms (2)

Lidocaine spray

EXPERIMENTAL

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

Procedure: Lidocaine spray

Lidocaine submucosal injection

ACTIVE COMPARATOR

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

Interventions

Lidocaine sprayPROCEDURE

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

Lidocaine spray
Lidocaine submucosal injectionPROCEDURE

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

Lidocaine submucosal injection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any degrees of cervical dysplasia detected from cervical cytology or histology
  • Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Related Publications (1)

  • Vanichtantikul A, Charoenkwan K. Lidocaine spray compared with submucosal injection for reducing pain during loop electrosurgical excision procedure: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):553-7. doi: 10.1097/AOG.0b013e31829d888e.

    PMID: 23921860DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kittipat Charoenkwan, M.D.

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

  • Asama Vanichtantikul, M.D.

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 9, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

TH(1)