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CompletedNCT03100565Updated Mar 13, 2018

Lidocaine Spray vs Coughing for Pain Relief During Colposcopy

An interventional study of local lidocaine spray and forced coughing in Colposcopy, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Colposcopy

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Keywords

  • colposcopy
  • pain
  • coughing
  • anesthetic spray
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 96 is above the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy,
  • Presence of already known invasive cancer,
  • Allergy to anesthetic agents.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • Placebo comparator
    colposcopic biopsy under local anesthetic sp

    Drug: local lidocaine spray

  • Placebo comparator
    Patients underwent colposcopic biopsy under forced coughing

    Other: forced coughing

Interventions

  • Druglocal lidocaine spray

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

  • Otherforced coughing

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

06

What researchers measure

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''

    Time frame: 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

    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''

    Time frame: 30. Min

07

Study locations

1 site
  • Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
    Van, 65000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100565
Lead sponsor
Yuzuncu Yıl University
Responsible party
erbil karaman (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
Apr 4, 2017
Start date
Sep 2016
Primary completion
Mar 8, 2018
Completion
Mar 10, 2018
Last update
Mar 13, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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