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


Phase 3
18 Years
N/A
Not Enrolling
Female
Uterine Cervical Dysplasia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Visual analog pain scores immediately after the excision

Outcome Time Frame:

Immediately after the excision

Safety Issue:

Yes

Principal Investigator

Kittipat Charoenkwan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chiang Mai University

Authority:

Thailand: Ethical Committee

Study ID:

OBG-11-08-15A-12

NCT ID:

NCT01505920

Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Uterine Cervical Dysplasia
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia

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