Uterine Cervical DysplasiaPhase 3NCT01505920
Lidocaine Spray Compared With Submucosal Injection During LEEP: a Randomized Controlled Trial
A Phase 3 study testing Lidocaine spray and Lidocaine submucosal injection in people with Uterine Cervical Dysplasia, run by Chiang Mai University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Dysplasia
- What is being tested?
- Lidocaine spray and Lidocaine submucosal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any degrees of cervical dysplasia detected from cervical cytology or histology
- Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment
Who cannot join
- 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
Show all 10Show fewer
- Coagulation defect
- Drug dependence
- Lower genital tract infection
- Obvious invasive disease of the cervix
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
About this study
Official title: Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
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.
- Conditions
- Uterine Cervical Dysplasia
- Being tested
- Lidocaine spray, Lidocaine submucosal injection
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine sprayProcedure or surgery
10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
Lidocaine submucosal injectionProcedure or surgery
2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine spray | Experimental | 10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision Receives: 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 Receives: Procedure: Lidocaine submucosal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain scores immediately after the excision
Measured: Immediately after the excision
Secondary outcomes (2)
Visual analog pain scores at the time of anesthetic application
Measured: At the time of anesthetic application
Visual analog pain scores at 30 minutes after the procedure
Measured: At 30 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, M.D., Chiang Mai University
- Investigators
- Kittipat Charoenkwan, M.D., Principal investigator, Chiang Mai UniversityAsama Vanichtantikul, M.D., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505920
- Sponsor's protocol ID
- OBG-11-08-15A-12
- Status last verified
- Jan 2013
- First submitted
- 5 Jan 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23921860
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01505920
- Acronym / sponsor ID
- OBG-11-08-15A-12
- Conditions
- Uterine Cervical Dysplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine spray | Experimental | Procedure: Lidocaine spray10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision |
| Lidocaine submucosal injection | Active comparator | Procedure: Lidocaine submucosal injection2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally to the four quadrant of the cervix, 3 minutes before starting cervical excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any degrees of cervical dysplasia detected from cervical cytology or histology
- Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment
Key exclusion criteria (10 listed)
- Allergy to lidocaine
- Pregnancy
- Previous history of cervical operation including conization, LEEP, laser therapy and cryotherapy
- Cardiac arrhythmia
- Neural disease with impaired sensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine spray10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision | Procedure or surgery | Lidocaine spray |
| Lidocaine submucosal injection2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision | Procedure or surgery | Lidocaine submucosal injection |
Primary outcome
Visual analog pain scores immediately after the excision
Time frame: Immediately after the excision
2 secondary outcomes
Visual analog pain scores at the time of anesthetic application
Time frame: At the time of anesthetic application
Visual analog pain scores at 30 minutes after the procedure
Time frame: At 30 minutes after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 23921860Vanichtantikul 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.
Related trials for Uterine Cervical Dysplasia
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Not yet recruiting
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
Human Papillomavirus (HPV), HPV Associated Cancers
Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Not yet recruitingPhase 2
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
Cervical Intraepithelial Neoplasia Grade 3
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kittipat Charoenkwan, M.D. principal investigator
Chiang Mai University
Asama Vanichtantikul, M.D. principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine spray and Lidocaine submucosal injection in people with Uterine Cervical Dysplasia, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain scores immediately after the excision (time frame: Immediately after the excision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.