Comparison of the analgesia effect of ketamine and magnesium sulfate in supraclavicular block in radius fracture surgeries.
Design
Patients will be randomly divided into three equal groups (30 people) using opaque envelopes sealed by computer sequence. The study will be randomly divided into 2 groups. Receiving group: ketamine and lidocaine control group. They are randomly divided into 2 groups. The way of randomization is that people are divided into four groups based on the first random permutation of 4 completely randomly, by a person who has no involvement in the study process. Mention randomization, sample size, and trial phase. For example: a clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 30 patients in each group, rand function of Excel software was used for randomization.
Settings and conduct
Patients with radius fracture referred to the orthopedic department of Imam Khomeini Hospital in Ahvaz were included in the study. The patients, the interventionist, and the person who examined the results did not know what group the people were in, and the study will be conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
Admission requirements: patients aged 21 to 65 (of both sexes)
Exclusion criteria: including the patient's refusal
Intervention groups
The study is randomly divided into 2 groups. Receiving group: ketamine and lidocaine control group
Main outcome variables
The primary outcome of this study was to evaluate the onset and duration of sensory and motor block of ketamine versus magnesium sulfate when added to lidocaine in ultrasound-guided SBP. Fees are recorded.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231125060169N1
Registration date:2024-05-31, 1403/03/11
Registration timing:prospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Mana Zamanpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3314 0000
Email address
manazamanpoor76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesia effect of ketamine and magnesium sulfate in supraclavicular block in radius fracture surgeries
Public title
Comparison of the analgesia effect of ketamine and magnesium sulfate in supraclavicular block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 21 to 65 years
Patients with radius fracture surgeries
Exclusion criteria:
Patient refusal
individual sensitivity to the drugs used
coagulation, local skin infection
severe lung diseases
inability to consent to participate in the study
any drug or opium abuse.
Age
From 21 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups, A, B, and C, and block randomization methods were used. The size of the block was six, and in each block, 2 people were assigned to group A, 2 people to group B, and 2 people to group C. The order of groups A, B, and C inside each block was randomly determined using the (RAND) function in Excel software. They did not know and the study was conducted in a double-blind manner.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the interventionist, and the person who examined the results did not know which group the people were in, and the study will be conducted in a double-blind manner. They will be placed equally (30 people).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Medical Sciences Boulevard, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.AJUMS.REC.1403.050
Health conditions studied
1
Description of health condition studied
Radius Fractures
ICD-10 code
S52.59
ICD-10 code description
Other fractures of lower end of radius
Primary outcomes
1
Description
Beginning of sensory and motor block
Timepoint
End of study
Method of measurement
Ultrasound guidance
2
Description
Duration of sensory and motor block
Timepoint
End of study
Method of measurement
Ultrasound guidance
Secondary outcomes
1
Description
pain scale
Timepoint
End of study
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1: Ketamine group (group K): 25 ml lidocaine 1% plus 0.5 mg/kg ketamine (12.5 mg/ml; Genmancy Panpharma company) (volume 5 ml);
Category
Treatment - Surgery
2
Description
Intervention group 2: Magnesium sulfate group (Saman Pharmaceutical Company, Mashhad-Iran and Shahid Ghazi Pharmaceutical Company) (M group): ml lidocaine 2% plus 250 mg magnesium sulfate (100 mg/ml) (volume 5 ml)
Category
Treatment - Surgery
3
Description
Control group: 25 ml of lidocaine 1% (Saman Pharmaceutical Company, Mashhad-Iran) (10 mg/ml) plus 5 ml of normal saline serum
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ali Ghomeishi
Street address
Ahvaz, Farvardin Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
ghomeishi-a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Street address
Ahvaz, Farvardin Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
ghomeishi-a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Farvardin Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
ghomeishi-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Farvardin Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
ghomeishi-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz, Farvardin Boulevard, Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3001
Email
ghomeishi-a@ajums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available