Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

NCT03100565 | Completed DMC

• 1 other identifier: YuzuncuYıl
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Colposcopy

Keywords

colposcopy; pain; coughing; anesthetic spray

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  30. Min

Study Arms (2)

colposcopic biopsy under local anesthetic sp

PLACEBO COMPARATOR

Drug: local lidocaine spray

Patients underwent colposcopic biopsy under forced coughing

PLACEBO COMPARATOR

Other: forced coughing

Interventions

local lidocaine spray DRUG

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

colposcopic biopsy under local anesthetic sp

forced coughing OTHER

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

Patients underwent colposcopic biopsy under forced coughing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age \>18,
• Presence of cervix,
• Patients who need a diagnostic work up for abnormal cervical smear results.

You may not qualify if:

• Pregnancy,
• Presence of already known invasive cancer,
• Allergy to anesthetic agents.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

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

Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Cough

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded to the methods used for pain relief.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 4, 2017
• Study Start: September 1, 2016
• Primary Completion: March 8, 2018
• Study Completion: March 10, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)