Assessing the relevance between age and the effectiveness of Diclofenac Suppository,
Assessing the relevance between addiction and the effectiveness of Diclofenac Suppository,
Assessing the relevance between surgery time and the effectiveness of Diclofenac Suppositoy
Design
Clinical trial, without control group, phase 2, on 44 patients that candidated for Mastectomy that was referred to the Khatam-al-Anbia Hospital in Shahrood in 98-99.
Settings and conduct
After the surgery, thr duration of surgery recorded in the questionnaire and Diclofenac suppository is given to the patient and pain intensity is measured at zero and 10 oclock at night
Participants/Inclusion and exclusion criteria
Informed consent
Age 18 years old and more
The patient it candidate for Mastectomy
Intervention groups
The patients are candidate for Mastectomy
Main outcome variables
Assessing the effectiveness of Diclofenac Suppository on post-operative pain of mastectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051191N1
Registration date:2021-06-01, 1400/03/11
Registration timing:retrospective
Last update:2021-06-01, 1400/03/11
Update count:0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Naghmeh Soroosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 1761
Email address
naghiii.sss.1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2021-03-20, 1399/12/30
Trial completion date
2021-03-20, 1399/12/30
Scientific title
Assessing the effect of Diclofenac suppository on post-operative pain of Mastectomy
Public title
Assessing the effect of Diclofenac suppository on post-operative pain of Mastectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age 18 years old and more
The patient it candidate for Mastectomy
Exclusion criteria:
The patients disappointment
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Shahrood
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.044
Health conditions studied
1
Description of health condition studied
The effectiveness of Diclofenac suppository
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain after Mastectomy
Timepoint
Immediately after surgery and 10 oclock at night
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diclofenac suppository, 100 mg, after the surgery
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-al-Anbia Hospital
Full name of responsible person
Naghmeh Soroosh
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2915
Email
naghiii.sss.1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
mohammad hossein hasani
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
naghiii.sss.1994@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Amirkhalili
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Email
www.naghiii.sss.1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Amirkhalili
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2915
Email
www.naghiii.sss.1994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Fatemeh Amirkhalili
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Khatam-al-Anbia Hospital, Daneshgah Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2915
Email
www.naghiii.sss.1994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available