Comparison the effect of hematoma block with injection of Lidocaine versus hematoma block with injection of Lidocaine plus ketamine on reduction of pain in patients with distal radius fracture
Determining and comparing the effect of block hematoma with lidocaine injection alone compared to lidocaine with ketamineat the onset of analgesia and reduction of pain during reduction and afterwards in patients with distal radius fracture
Design
In this randomized double-blind clinical trial study of phase 3, 60 patients with distal radius fracture underwent simple random assignment in two groups receiving libidocaine injection, only volidocaine with ketamine.
Settings and conduct
This clinical trial study is performed in 1400 in Alzahra hospitals of Isfahan . The study population is patients with distal radius fracture.
Participants/Inclusion and exclusion criteria
Inclusion criteria: distal radius bone fracture that requires reduction by a physician; age older than18 years old; consent to study; absence of trauma in other areas of the body; especially the patient's head; lack of bone abnormalities and previous fractures in the location of the radius bone is insensitivity to lidocaine and ketamine. Exclusion criteria: drug and alcohol addiction; coagulation disorders; psychiatric disorders; liver disorders, epilepsy, hypertension and heart rate less than 55 and patient dissatisfaction to continue the study.
Intervention groups
60 patients with distal radial fractures are assigned in two groups. In the first group, 8 mg of lidocaine 2% and in the second group, 8 mg of lidocaine with 0.5 mg of ketamine is injected.
Main outcome variables
The severity of pain during radius implantation and patient satisfaction are the main outcomes of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200622047874N2
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
marjan zareian jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 6557
Email address
zareiian@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of hematoma block with injection of Lidocaine versus hematoma block with injection of Lidocaine plus ketamine on reduction of pain in patients with distal radius fracture
Public title
Comparison the effect of hematoma block with injection of Lidocaine versus hematoma block with injection of Lidocaine plus ketamine on reduction of pain in patients with distal radius fracture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Distal radius fracture that requires reduction by a physician
Age over 18 years old
Satisfaction to enter the study
Absence of trauma in other areas of the body, especially the patient's head
Absence of bone abnormalities and previous fractures at the site of the radius bone
Hypersensitivity to lidocaine and ketamine
Exclusion criteria:
Drug and alcohol addiction
Having coagulation diseases
Psychiatric disorders
Liver disorders
Epilepsy
Hypertension and heart rate less than 55
Patient dissatisfaction to continue the study
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is performed using random allocation software (RAS). In this software, the total sample size and number of groups are entered into the software. The software output includes a list that distributes the total sample size by number between the two groups. Patients are distributed in two groups according to the list and in order of referral time to complete the sample size in both groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind study and patients and researchers are unaware of the type of drug injected to patients. The drugs are prepared and coded by one of the operating room staff in a syringe and given to the researcher for injection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jareeb
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-06-21, 1397/03/31
Ethics committee reference number
IR.MUI.REC.1397.174
Health conditions studied
1
Description of health condition studied
radius fracture
ICD-10 code
S52. 5
ICD-10 code description
radious fracture
Primary outcomes
1
Description
Patients' pain score during manipulation (reduction)
Timepoint
At the time of fracture placement and 1 and 6 hours later
Method of measurement
Visual analog scale (VAS) that divides pain intensity from zero to ten
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
In the 6 hour after fracture placement
Method of measurement
Likert criteria for satisfaction, completely satisfied, satisfied, dissatisfied, dissatisfied and completely dissatisfied
Intervention groups
1
Description
intervention group 1: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, block hematoma is performed by injecting 8 ml of 2% lidocaine with 0.5 mg kg of ketamine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency rooms of Al-Zahra hospitals in Isfahan
Full name of responsible person
Dr. Azardokht Rahimi Nik
Street address
Hezar Jareeb St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
azinik11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research Deputy, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3070
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Azardokht Rahimi Nik
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jareeb St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
azinik11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Azardokht Rahimi Nik
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jareeb St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
azinik11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Azardokht Rahimi Nik
Position
َAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jareeb St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
azinik11@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to the government organization and it is not possible to share it