Condition category
Surgery
Date applied
08/06/2009
Date assigned
09/07/2009
Last edited
24/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mehmet Murat Naki

ORCID ID

Contact details

Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Turkey
mmuratnaki@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparative study of local anaesthesia, forced coughing and no anaesthesia for pain reduction in colposcopically directed cervical punch biopsies: a randomised trial

Acronym

Study hypothesis

Is there any differences between local anaesthesia, forced coughing and no local anaesthesia for pain reduction in cervical punch biopsies?

Ethics approval

Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 18/28.05.2009)

Study design

Randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Abnormal pap smear/cervical punch biopsy

Intervention

Please note that as of 24/11/09, the end date of this trial had been extended from 01/09/09 to 01/12/09.

This trial is taking place at the Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynaecology. Approximately 114 patients will be recruited, 38 patients in each of the following three groups:
1. Local anaesthesia with lidocaine
2. Forced coughing
3. No local anaesthesia

Patient allocation will be carried out as follows:
A computer based randomisation will be prepared. The anaesthesia type will be printed on identical sheets of paper, which will be put into identical, consecutively numbered sealed opaque envelopes by a non-participating colleague.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Pain score when the first biopsy performed

Secondary outcome measures

Pain score for overall procedure

Overall trial start date

01/06/2009

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women between ages of 18 - 65 years
2. Abnormal pap smears indicated cervical punch biopsy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Approximately 114

Participant exclusion criteria

1. Any contraindications for parenteral analgesics
2. Any contraindications for lidocaine
3. Pregnancy

Recruitment start date

01/06/2009

Recruitment end date

01/12/2009

Locations

Countries of recruitment

Turkey

Trial participating centre

Cihat Saran Sk. Cagdas Apt. No:11/3
Istanbul
34841
Turkey

Sponsor information

Organisation

Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)

Sponsor details

c/o M. Murat Naki
Department of Obstetrics and Gynaecology
Istanbul
34841
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes