Protocol summary

Study aim
Comparison of the results of using Walant solution together with dexmedetomidine on block duration, block initiation and postoperative analgesia with Walant solution alone in distal radius fracture surgery
Design
در یک گروه تکنیک های WALANT (بی حسی موضعی بیدار کامل بدون استفاده از تورنیکت) در محل جراحی و در گروه دیگر همین تکنیک که به آن محلول دکسمدتومیدین اضافه شده است تزریق می شود
Settings and conduct
After transferring the patient to the operation room of Shahada Tajrish hospital and standard monitoring and fluid therapy, oxygen 5 lit/min is prescribed through a mask and then Walant solution containing 20 ml of lidocaine 2% along with 2 CC of epinephrine vial 1000/01 to Along with 14 CC of normal saline and 4 CC of 8.4% sodium bicarbonate (40 CC in total) for the control group and the same solution plus 5 micrograms per kilogram of body weight of dexmedetomidine for the intervention group is injected at the operation site.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 80 years with distal radius fracture are included in the study, and patients with active site infection, peripheral vascular disease, anxiety, severe fear of injection, impaired coagulation profile, open fracture, and fracture more than 3 weeks old are excluded
Intervention groups
In the control group, surgery with local anesthesia of Walant solution containing 20 ml of lidocaine 2% along with 2 CC of epinephrine 01/1000 vial along with 14 CC of normal saline and 4 CC of sodium bicarbonate 8.4%, a total of 40 CC and in the group The intervention of this solution plus 5 micrograms per kilogram of dexmedetomidine is used
Main outcome variables
The amount of pain during and after surgery, the hemodynamic status during surgery, the amount of bleeding during surgery and the limitation of wrist movements after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210216050379N4
Registration date: 2023-04-05, 1402/01/16
Registration timing: prospective

Last update: 2023-04-05, 1402/01/16
Update count: 0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Hamidreza Azizifarsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
h.faresani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of adding dexmedetomidine to standard Walant solution in local anesthesia of patients with distal radius fracture on postoperative complications.
Public title
New technique of distal radius surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Distal radius fracture requiring surgery for fixation
Exclusion criteria:
Active surgical site infection Peripheral vascular disease anxiety Impaired coagulation profile Phobia of injections
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done by dividing included patients into some blocks of size 2n( 2,4,6,8 and...), then randomizing patients in each block will be done such that n patients are allocated to the experimental group and control group. then we will choose the blocks randomly. This method ensures equal treatment allocation within each block when the complete block is used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak street
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.281

Health conditions studied

1

Description of health condition studied
Distal radius fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius

Primary outcomes

1

Description
Pain
Timepoint
During and immediately after surgery
Method of measurement
Visual analogue scale

2

Description
Hemodynamic status during surgery
Timepoint
During surgery
Method of measurement
Monitoring during surgery

3

Description
Bleeding volume during surgery
Timepoint
during surgery
Method of measurement
Blood volume measurement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For patients with distal radius fractures, Walant solution containing 20 ml of 2% lidocaine with 2 CC of 1000/01 epinephrine vial, 14 CC of normal saline and 4 CC of 8.4% sodium bicarbonate (40 CC in total) and the same solution in addition 50 micrograms per kilogram of their weight, dexmedetomidine is injected at the site of operationp:
Category
Treatment - Surgery

2

Description
Control group: patients with distal radius fracture who received Walant solution with WALANT technique (full awake local anesthesia without using tourniquet) including 20 ml lidocaine 2% with 2 CC of epinephrine 01/1000 vial, with 14 CC of normal saline and 4 CC They receive 8.4% sodium bicarbonate (40 CC in total) at the surgical site
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Hamidreza Azizifarsani
Street address
Tajrish squre
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2238 2080
Email
h.faresani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research,Afshin Zarghi
Street address
Bldg, No2, Shahid Beheshti University of Medical sciences, Arabi Ave, Daneshjoo Blvd, velenjak,
City
Tehran
Province
Tehran
Postal code
1981958379
Phone
+98 21 2243 2572
Email
h.faresani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Azizifarsani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
NO.1,Shahid Lamee st, Faraze, Tehran
City
Tehran
Province
Tehran
Postal code
1981956316
Phone
+98 21 2238 2080
Email
h.faresani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Azizifarsani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 1, Shahid Lamee st, Faraz,Tehran
City
Tehran
Province
Tehran
Postal code
1981956316
Phone
+98 21 2238 2080
Email
h.faresan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Azizifarsani
Position
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No1, Shahid Lamee st, Faraze, Tehran
City
Tehran
Province
Tehran
Postal code
1981956316
Phone
+98 21 2238 2080
Email
h.faresani@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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