Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

March 11, 2018 updated by: erbil karaman, Yuzuncu Yıl University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65000
        • Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 0-1 min
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
Time Frame: 30. Min
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

March 8, 2018

Study Completion (Actual)

March 10, 2018

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 11, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YuzuncuYıl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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