Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

Colposcopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100565
• Other study ID #: YuzuncuYil
• Status: Completed
• Phase: N/A
• First received: March 17, 2017
• Last updated: March 11, 2018
• Start date: September 2016
• Est. completion date: March 10, 2018

Study information

• Verified date: March 2018
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 10, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colposcopy
• Cough

Intervention

Drug:
• local lidocaine spray
The lidocaine spray will be introduced to the cervix just before the biopsy procedure

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

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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