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

ISRCTN	ISRCTN34193340
DOI	https://doi.org/10.1186/ISRCTN34193340
Secondary identifying numbers	N/A

Submission date: 08/06/2009
Registration date: 09/07/2009
Last edited: 24/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mehmet Murat Naki
Scientific

Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye

Email	mmuratnaki@yahoo.com

Study information

Study design	Randomised controlled single centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparative study of local anaesthesia, forced coughing and no anaesthesia for pain reduction in colposcopically directed cervical punch biopsies: a randomised trial
Study objectives	Is there any differences between local anaesthesia, forced coughing and no local anaesthesia for pain reduction in cervical punch biopsies?
Ethics approval(s)	Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 18/28.05.2009)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Pain score when the first biopsy performed
Secondary outcome measures	Pain score for overall procedure
Overall study start date	01/06/2009
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Female
Target number of participants	Approximately 114
Key inclusion criteria	1. Women between ages of 18 - 65 years 2. Abnormal pap smears indicated cervical punch biopsy
Key exclusion criteria	1. Any contraindications for parenteral analgesics 2. Any contraindications for lidocaine 3. Pregnancy
Date of first enrolment	01/06/2009
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

Türkiye

Study participating centre

Cihat Saran Sk. Cagdas Apt. No:11/3

Istanbul
34841
Türkiye

Sponsor information

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

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

"ROR"	https://ror.org/01c2wzp81

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan