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Evaluation of the effect of topical tranexamic acid administration in preventing hematoma, swelling and pain after carpal tunnel syndrome surgery

Protocol summary

Study aim
Determining the effect of local tranexamic acid on post operation of carpal tunnel syndrome hematoma, swelling and pain .
Design
A clinical trial with a control group with a parallel group, triple blind, randomized phase 3 on 52 patients will be used for randomization using the rand function of Excel software.
Settings and conduct
This study is conducted in Besat Hospital in Hamadan, on patients with bilateral carpal tunnel syndrome who are candidates for surgery, in a triple-blind manner. All surgeries will be performed by one surgeon. On the intervention side, after the surgery, Transgamic acid is injected into the flexor sheet, but on the control side, after the surgery, normal saline is used inside the flexor sheet. day and will receive acetaminophen. The duration of the surgery, the amount of blood lost during the surgery and the hematoma and other surgical outcomes will be recorded in the checklist on the day after the operation, the second week and the fourth week and three months after the operation.
Participants/Inclusion and exclusion criteria
Patients with bilateral carpal tunnel syndrome. Inclusion criteria in the study: not using anti-anxiety and hypnotic drugs and painkillers and hemoglobin >10. Conditions of non-entry: history of coagulopathy, history of bilateral surgery, Allergy to tranexamic acid, contraindication for spinal anesthesia and allergy to anesthetics and other drugs.
Intervention groups
In the first group, in the intervention side, after the end of the surgery, Transgamic acid will be injected into the flexor sheet, but in the control side, after the end of the surgery, normal saline will be injected inside the flexor sheet.
Main outcome variables
The main outcomes include hematoma, swelling and pain, which will be recorded in the checklist on the day post operation, the second week and the fourth week and three months after the operation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N32
Registration date: 2023-10-24, 1402/08/02
Registration timing: prospective

Last update: 2023-10-24, 1402/08/02
Update count: 0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical tranexamic acid administration in preventing hematoma, swelling and pain after carpal tunnel syndrome surgery
Public title
Prevention of hematoma, swelling and pain after carpal tunnel syndrome surgery with tranexamic acid
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of bilateral carpal tunnel syndrome that requires surgery Not using anti-anxiety, hypnotic and sedative drugs Hemoglobin >10
Exclusion criteria:
History of coagulopathy Allergy to tranexamic acid Contraindication for spinal anesthesia and allergy to anesthetics and other drugs.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, the block randomization method of 50 blocks will be used. In this block, each cells contains the letters RA-LB (meaning the right hand of drug A and the left hand of drug B) or RB-LA (the right hand of drug B). and the left hand of drug A) which are randomly distributed. With the referral of each of the qualified patients, one of the houses is randomly selected and according to whether it is RA-LB or RB-LA. Right and left hand medicine type will be selected. And the selected cell will be crossed with a red pen in order not to be selected again. Codes A and B (normal saline or tranexamic acid) will be revealed at the end of the study and after the analysis.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Transgamic acid and normal saline will be drawn in syringes of the same color and shape with codes A and B by the operating room technician, and the codes will remain secret with this person until the end of the research. Therefore, the patient, the surgeon who will measure and record the outcome of the study, and the statistical consultant will will be blind about the contents of the syringe used, and the study will be performed in a triple blind manner.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517789971
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.UMSHA.REC.1402.286

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
24 hours, 2 weeks, 1 month and 3 months post operation
Method of measurement
Clinical Examination

2

Description
Swelling
Timepoint
24 hours, 2 weeks, 1 month and 3 months post operation
Method of measurement
Clinical Examination

3

Description
Pain
Timepoint
24 hours, 2 weeks, 1 month and 3 months post operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the completion of carpal tunnel syndrome surgery, two ampoules of tranexamic acid (2 grams) will be injected into the flexor sheet.
Category
Treatment - Drugs

2

Description
Control group: After the completion of carpal tunnel syndrome surgery, normal saline will be used inside the flexor sheet
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr. Bijan Heidari
Street address
Besat Hospital, Shahid Beheshti Blvd, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medicine School, Shahid Fahmideh Street, Hamadan
City
Hamثdan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bijan Heidari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Email
b.heidari@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medicine School, Shahid Fahmide Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2024 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
To develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document
Send and receive email
Comments
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