Determination of the effect of topical amitriptyline, ketamine and Baclofen gel for pain relief after mastectomy in patients with breast cancer
Design
A clinical trial with a parallel control group, double blind, randomized
Settings and conduct
After obtaining permission from the Assistant Professor of Research, 60 patients were selected in three groups of 20, one combination group and the other in the placebo group, and one group received no medication. The gel has been used locally in the pain area and should not be taken from more than 4 areas each time. Before and 4 weeks after the study, the patient's pain was recorded based on the VAS criteria, which is based on the patient's score of 0 to 10. Also, the dose of duloxetine administered to each patient after the completion of the 4-week period, if changed in the relevant checklist It turns out. All patients are also monitored for possible complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pain syndrome after mastectomy; At least 1 month has passed surgery; Not having other neuropathic conditions, such as shingles and diabetic neuropathy; Exclusion criteria: The presence of open sore in the surgical site; Taking painkillers
Intervention groups
Patients are randomly divided into intervention and control groups.
The intervention groups, including a baclofen-amitriptyline-ketamine combination gel recipients and and a placebo gel recipient group, and control group do not receive any medication.
Main outcome variables
Quality of life; irritation; anesthesia; pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N13
Registration date:2019-05-25, 1398/03/04
Registration timing:prospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-06-24, 1398/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the effect of topical amitriptyline, ketamine and Baclofen gel for pain relief after mastectomy in patients with breast cancer
Public title
The effect of amitriptyline, ketamine and Baclofen gel for pain relief after mastectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain syndrome after mastectomy
At least 1 month has passed surgery
Not having other neuropathic conditions, such as shingles and diabetic neuropathy
Exclusion criteria:
The presence of open sore in the surgical site
Taking painkillers
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the three groups by selecting the cards named A, B and C.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were packaged in the same package by the pharmacist, and none of the patients and researchers knew about their contents.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.SKUMS.REC.1397.092
Health conditions studied
1
Description of health condition studied
Mastectomy
ICD-10 code
Z42.1
ICD-10 code description
Encounter for breast reconstruction following mastectomy
Primary outcomes
1
Description
Quality of life
Timepoint
Before and 4 weeks after study
Method of measurement
SF 36 questionnaire
2
Description
Irritation
Timepoint
Before and 4 weeks after study
Method of measurement
Check list
3
Description
anesthesia
Timepoint
Before and 4 weeks after study
Method of measurement
Check list
4
Description
Pain
Timepoint
Before and 4 weeks after study
Method of measurement
VAS benchmark
Secondary outcomes
empty
Intervention groups
1
Description
Intervention first group: Daily, a baclofen-amitriptyline-ketamine combination gel twice a day (morning and night) at a dose of 1.3 g, is equivalent to one tbsp of topical.
Category
Treatment - Drugs
2
Description
Intervention group: Daily, a placebo gel twice a day (morning and night) at a dose of 1.3 g, is equivalent to one tbsp of topical.
Category
Placebo
3
Description
Control group: Do not get any medication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Rouhollah Masoumi
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Rmasomi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
nmaleeky@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Rohollah Masoumi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 913 284 1574
Fax
Email
Rmasomi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Rohollah Masoumi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 913 284 1574
Fax
Email
Rmasomi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Rohollah Masoumi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 913 284 1574
Fax
Email
Rmasomi@gmail.com
Web page address
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
No - There is not 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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Imam Ali Clinic
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.