Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

Study Overview
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Brief Summary
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Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.

Official Title
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Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial

Conditions
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Colposcopy

Intervention / Treatment
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* Drug: local lidocaine spray
* Other: forced coughing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age >18, Presence of cervix, Patients who need a diagnostic work up for abnormal cervical smear results. Exclusion Criteria: Pregnancy, Presence of already known invasive cancer, Allergy to anesthetic agents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: colposcopic biopsy under local anesthetic sp<br> | Drug: local lidocaine spray<br>* The lidocaine spray will be introduced to the cervix just before the biopsy procedure<br>|
| Placebo Comparator: Patients underwent colposcopic biopsy under forced coughing<br> | Other: forced coughing<br>* The patients will be asked to forced coughing during the biopsy procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system | The perceived pain will be measured during the biopsy procedure. It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain'' | 0-1 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system | The perceived pain will be measured after the biopsy procedure (at the 30th min). It will be evaluated by the 0-10 cm scale of VAS scoring system. The patient will be asked to rate her pain as 0 corresponds ''no pain'' and 10 to the '' worst pain'' | 30. Min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colposcopy, pain, coughing, anesthetic spray