Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

NCT ID: NCT03100565

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-10

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.

Detailed Description

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Conditions

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Colposcopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The participants will be blinded to the methods used for pain relief.

Study Groups

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colposcopic biopsy under local anesthetic sp

Group Type PLACEBO_COMPARATOR

local lidocaine spray

Intervention Type DRUG

The lidocaine spray will be introduced to the cervix just before the biopsy procedure

Patients underwent colposcopic biopsy under forced coughing

Group Type PLACEBO_COMPARATOR

forced coughing

Intervention Type OTHER

The patients will be asked to forced coughing during the biopsy procedure

Interventions

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local lidocaine spray

The lidocaine spray will be introduced to the cervix just before the biopsy procedure

Intervention Type DRUG

forced coughing

The patients will be asked to forced coughing during the biopsy procedure

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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erbil karaman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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YuzuncuYıl

Identifier Type: -

Identifier Source: org_study_id

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