Evaluation of the results of using the walant technique in open surgery of clavicle fractures with the help of a plate with a diameter of 3.5 mm
Design
Phase 2 clinical trial in patients with acute clavicle fractures requiring fixation surgery that the control group does not have.
Settings and conduct
Included patients will be transferred to the operating room and first WALANT solution is injected for them and then the patients are transferred to the operating table and undergo surgery. The WALANT is 200 cc of a solution containing 50 ccs of 1% lidocaine and 5 ccs of 7.5% sodium bicarbonate, 1 cc of adrenaline, and normal saline.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 16 to 60 years with acute clavicle fractures require fixation surgery. Exclusion criteria are patients with cardiovascular problems or with a history of seizure and psychiatric problems, open fractures, fractures with vascular-neurological damage, and other serious injuries in the shoulder girdle.
Intervention groups
Patients aged 16 to 60 years with acute clavicle fractures require fixation surgery operated with open clavicle surgery with WALANT techniques ( wide awake local anesthesia no tourniquet)
Main outcome variables
During and after the operations, various factors such as pain, bleeding and range of motion, patient activity, and surgical complications are collected by a pre-prepared questionnaire.During the patient's hospitalization, we consider and follow the patient's bleeding volume and wound problems.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053235N2
Registration date:2022-01-27, 1400/11/07
Registration timing:prospective
Last update:2022-01-27, 1400/11/07
Update count:0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
Meisam Jafari Kafiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.jafari8567@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-05, 1400/11/16
Expected recruitment end date
2022-05-06, 1401/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Walant technique for clavicle fracture fixation with anatomic locking plate with diameter 3.5 millimeters
Public title
Open surgical treatment of clavicle fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute clavicle fracture requires fixation surgery
Exclusion criteria:
Patients with cardiovascular problems
Patients with history of seizure
Patients with history of psychiatry disorders
Patients with open clavicle fractures
Fractures associated with vascular-neurological damage
Serious injury to the shoulder girdle
Age
From 16 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yemen Street, Shahid Chamran Highway, Iran, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.764
Health conditions studied
1
Description of health condition studied
Fracture of clavicle
ICD-10 code
S42.0
ICD-10 code description
Fracture of clavicle
Primary outcomes
1
Description
Pain
Timepoint
2 weeks, 6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
visual analogue scale
2
Description
bleeding volume during surgery
Timepoint
2 weeks, 6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
Blood volume measurement
3
Description
union of bones
Timepoint
2 weeks, 6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
Assessment of the bony cortex on radiography
4
Description
Duration of hospitalization
Timepoint
2 weeks, 6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
Patients records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with open clavicle fracture surgery with the help of plaque with a diameter of 3.5 mm and anesthesia injection technique of 200 cc of solution containing 50 cc of 1% lidocaine and 5 cc of sodium bicarbonate 7.5%, 1 cc of adrenaline and normal saline
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr. Meisam Jafari Kafiabadi
Street address
Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dr.jafari8567@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yemen street, Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
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
Meisam Jafari Kafiabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Yemen street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
dr.jafari8567@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farsad Biglari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Yemen street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
biglari.farsad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meisam Jafari Kafiabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shohada-e tejrish hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2271 8000
Fax
Email
dr.jafari8567@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
After finishing patient recruitment
When the data will become available and for how long
After finishing patient recruitment
To whom data/document is available
After finishing patient recruitment
Under which criteria data/document could be used
After finishing patient recruitment
From where data/document is obtainable
After finishing patient recruitment
What processes are involved for a request to access data/document