The aim of this randomized controlled trial is to determine the effect of lidocaine 2% gel on pain from copper IUD insertion. It will be took place in Bavafa health center in Tabriz, a center with about 70 IUD insertion a month. In group 1, lidocaine 2% gel and in group 2, lubricant gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion and the group 3 will get no intervention. Immediately after IUD insertion, pain score will be assessed by the investigator using 10 cm visual scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903093706N3
Registration date:2010-09-21, 1389/06/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-21, 1389/06/30
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lidocaine gel on pain from copper IUD insertion: A randomized controlled trial
Public title
Effect of lidocaine gel on pain from copper IUD insertion: A randomized controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All IUD clients of Bavafa health center who have no IUD contraindication, including: Pregnancy, puerprium sepsis, pelvic inflammatory disease or sexually transmitted infections (currently or in past 3 months), known or suspected uterine or cervical cancer, unknown genital abnormal bleeding, uterine fibroids and tumors causing deformity in uterus. Exclusion criteria: any problem during IUD insertion for any reason; in this case another gel with the same number will be replaced.
Age
From 15 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy of Tabriz university of medical sciences
Street address
Golgasht St.
City
Tabriz
Postal code
118-51665
Approval date
empty
Ethics committee reference number
8918
Health conditions studied
1
Description of health condition studied
pain from copper IUD insertion
ICD-10 code
Z30.1
ICD-10 code description
Insertion of (intrauterine) contraceptive device
Primary outcomes
1
Description
pain severity
Timepoint
Immediately after IUD insertion
Method of measurement
10 cm visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Group 3 will get no intervention.
Category
N/A
2
Description
Group 1: lidocaine 2% gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion
Category
Prevention
3
Description
Group 2: lubricant gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bavafa health center
Full name of responsible person
Farideh Kazemi
Street address
Monajjem blvd
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Farideh Kazemi
Position
Midwifery graduate student
Other areas of specialty/work
Street address
Golgasht St.
City
Tabriz
Postal code
Phone
+98 81 1254 9670
Fax
Email
f.kazemi21@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
Assistant professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir , smoalch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Farideh Kazemi
Position
Midwifery graduate student
Other areas of specialty/work
Street address
Golgasht St.
City
Tabriz
Postal code
Phone
+98 81 1254 9670
Fax
Email
f.kazemi21@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)