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Completed

NCT Number: NCT03100565

Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

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.

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Key information

Conditions

Colposcopy Cough Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Van, 65000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

local lidocaine spray

Drug

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

forced coughing

Other

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

Primary outcomes

  1. 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''

Secondary outcomes

  1. 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''

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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