In this double blinded clinical trial, 50 patients with carpal tunnel syndrome requiring surgery will be randomly divided into two groups. In the intervention group, after complete hemostasis and tourniquet removal tranexamic acid will be introduced to the wound via a syringe, after which the wound is irrigated with normal saline. In the control group, placebo will be used. After surgery the patients will be followed in determined intervals and data registered in forms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605242115N4
Registration date:2017-08-01, 1396/05/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Ali Reza Saied
Name of organization / entity
Kerman Neurosceince research center, Kerman University of medical sciecnes
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 6432
Email address
arsaied@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of local tranexamic acid in prevention of hematoma formation and swelling after surgery for carpal tunnel syndrome
Public title
effect of local tranexamic acid in prevention of hematoma formation and swelling after surgery for carpal tunnel syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
1. informed consent for entrance to trial
2. Carpal tunnel syndrome diagnosis requiring surgery
exclusion criteria:
1.history of coagulation disorder
2.bilateral surgery
3.hypersensitivity to tranexamic acid
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Kerman University of Medical sciences
Street address
22 Bahman Blvd.
City
Kerman
Postal code
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.KMU.1396.1721
Health conditions studied
1
Description of health condition studied
Carpal Tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
hematoma
Timepoint
day after the operation, second and fourth week, 3 months afher the operation
Method of measurement
Wrsit circumference measurement
Secondary outcomes
1
Description
grip power
Timepoint
first, second and third month after the operation
Method of measurement
Jammar Dynamometer
Intervention groups
1
Description
In the intervention group 1 ampule of tranexamic acid is injected into flexor sheet.
Category
Prevention
2
Description
In the control group normal saline is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical sciences
Full name of responsible person
Dr Alireza Saied
Street address
Dr bahonar Hospital
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Saied
Position
Assistant Profesor of orthopedics
Other areas of specialty/work
Street address
Dr Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
arsaiedmd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical sciences
Full name of responsible person
Dr Alireza Saied
Position
Assistant Professor
Other areas of specialty/work
Street address
Orthopedics Dept.
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
arsaiedmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Alireza Saied
Position
Assistant Professor of Orthopedics
Other areas of specialty/work
Street address
Orthopedics Dept.
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
arsaiedmd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)