Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT03100565

Collaborator

(none)

Enrollment

Location

Arms

18.2

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colposcopy	Drug: local lidocaine spray Other: forced coughing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Mar 8, 2018

Actual Study Completion Date :

Mar 10, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system [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 Outcome Measures

Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system [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''

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology	Van		Turkey	65000

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

erbil karaman, Assistant Professor, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT03100565

Other Study ID Numbers:

YuzuncuYıl

First Posted:

Apr 4, 2017

Last Update Posted:

Mar 13, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by erbil karaman, Assistant Professor, Yuzuncu Yıl University

Additional relevant MeSH terms:

Cough

Lidocaine

Study Results

No Results Posted as of Mar 13, 2018