Determining the effectiveness of lidocaine spray in relieving pain caused by cervical biopsy through colposcopy
Design
This single-blind randomized clinical trial with parallel groups will be performed on 60 women candidates for colposcopy. Patients are randomly divided into two groups by block randomization. Prior to the biopsy, the intervention group will be received lidocaine 10% spray (4 puffs containing 10 mg per puff) over the entire length of the ectoservix, and the second group will be received placebo spray (normal saline).
Settings and conduct
This single-blind randomized clinical trial with parallel groups will be performed on 60 women candidates for colposcopy. It will be performed in a teaching hospital in Zanjan. In this study, patients, data collectors, outcome assessors, and manuscript writers will be completely unaware of the prescribing protocol.
Participants/Inclusion and exclusion criteria
Patients will be enrolled the study with abnormal cervix screening test or colposcopy findings with biopsy indication. Exclusion criteria include allergy to lidocaine , pregnancy and post-hysterectomy period.
Intervention groups
Prior to the biopsy, the intervention group will be received lidocaine 10% spray (4 puffs containing 10 mg per puff) over the entire length of the ectoservix, and the second group will be received placebo spray (normal saline).
Main outcome variables
Pain during and after biopsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220606055087N1
Registration date:2022-06-12, 1401/03/22
Registration timing:prospective
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
Zahra Ghomashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4252 7476
Email address
z.ghomashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-11, 1401/05/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of lidocaine spray in relieving pain caused by cervical biopsy through colposcopy
Public title
lidocaine spray in relieving pain caused by cervical biopsy through colposcopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with abnormal cervix screening test or colposcopy findings with biopsy indication
Exclusion criteria:
Lidocaine allergy
Pregnancy
Post-hysterectomy period
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. The size of all blocks is equal. Random allocation software is also used to generate a random sequence of blocks. This software generates a random sequence in addition to generating a random sequence by blocking method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the use of two sprays with similar shapes and colors in this study, patients and individuals performing statistical analysis and those who prepare the draft of article will be completely unaware of the treatment protocol.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1435689752
Approval date
2022-06-05, 1401/03/15
Ethics committee reference number
IR.ZUMS.REC.1401.071
Health conditions studied
1
Description of health condition studied
Pain after biopsy
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain after biopsy
Timepoint
Immediately after biopsy and 10 minutes after biopsy
Method of measurement
The Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In lithotomy position, after inserting a speculum, 4 puff of 10% concentration of lidocaine spray (each puff contains 10 mg of lidocaine) is sprayed in the vaginal area and cervix.
Category
Treatment - Drugs
2
Description
Control group: 4 puffs of normal salin spray
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Zahra Ghomashi
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Z.ghomashi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of Medical Sciences Campus, Dr. Yousef Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
riasat@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Ghomashi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Z.ghomashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Ghomashi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Z.ghomashi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Ghomashi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Z.ghomashi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including the main and secondary outcomes can be shared.
When the data will become available and for how long
Access period starts from 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
To receive the required documents or data, contact the Responsible person of the project (Dr. Zahra Ghomashi) by email: Z.ghomashi@yahoo.com.
What processes are involved for a request to access data/document
To receive the required documents or data, contact the Responsible person of the project (Dr. Zahra Ghomashi) by email: Z.ghomashi@yahoo.com and send a written and signed request to her.