Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
This study has been completed.
Sponsor:
Chiang Mai University
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
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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
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
| 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 May 23, 2013