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 |
| Protocol serial number | N/A |
| Sponsor | Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) |
| Funder | Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology |
- 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
Scientific
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Türkiye
| mmuratnaki@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Pain score when the first biopsy performed |
| Key secondary outcome measure(s) |
Pain score for overall procedure |
| 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 sample size at registration | 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
34841
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
