The aim of this study is pain assessment of endometrial pipelle biopsy in patients receiving different methods of local anesthesia. One hundred sixty premenopausal women referring to Alzahra hospital and candidate for outpatient endometrial biopsy due to AUB will be recruited in a double blind clinical trial from 2011 to 2013. The patients will be randomly allocated to receive intrauterine injection of 5 ml 2% lidocaine, cervical spray of 3 puff lidocaine, 3 puff cervical spray of lidocaine plus intrauterine 5 cc of 2% lidocaine, or intrauterine injection of 5 cc distilled water, before biopsy. Primary outcome of this study is pain intensity which be compared between different groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101135563N2
Registration date:2011-02-06, 1389/11/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-02-06, 1389/11/17
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Vice Chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the pain-relief effect of different methods of local anesthesia in outpatient endometrial biopsy
Public title
Evaluating the pain-relief effect of different methods of local anesthesia in outpatient endometrial biopsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of AUB, no active uterine bleeding, willing to participate in the study, premenopausal women between 40-55 years, parity more than or equal to 1
Exclusion criteria: pregnancy, suspicious to PID, known cervical stenosis, known uncompensated cardio-pulmonary failure, active hepatic disease, allergy to lidocaine, no cooperation to pain assessment by VAS, chronic pelvic pain, nulliparity
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht St.
City
Tabriz
Postal code
Approval date
2011-01-02, 1389/10/12
Ethics committee reference number
5/4/7975
Health conditions studied
1
Description of health condition studied
Abnormal uterine bleeding
ICD-10 code
N93.8
ICD-10 code description
Other specified abnormal uterine and vaginal bleeding
Primary outcomes
1
Description
Pain severity
Timepoint
during biopsy, immediately after biopsy, 15 min after biopsy
Method of measurement
visual analog scale
Secondary outcomes
1
Description
possible complications
Timepoint
during biopsy and after biopsy
Method of measurement
patient examination and questionnaire
Intervention groups
1
Description
Control group: recieving 5 ml distilled water intra uterus before biopsy.
Category
Placebo
2
Description
3 puffs lidocaine spray cervically 5 min before biopsy then 5 ml intra uterine 2% lidocaine solution 3 minutes before biopsy.
Category
Treatment - Drugs
3
Description
5 ml intra uterine 2% lidocaine solution 3 minutes before biopsy.
Category
Treatment - Drugs
4
Description
3 puffs lidocaine spray cervically 3-5 min before biopsy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South Artesh Ave., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, 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
Elaheh Ouladsahebmadarek
Position
Associate Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1554 1221
Fax
Email
elmadarek33@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Associate Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 1554 1221
Fax
Email
elmadarek33@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)