Investigating the effect of Dexmedetomidine and Ketamine as adjuvants in supraclavicular block in orthopedic surgery of the forearm in reducing postoperative pain
Investigating the effect of Dexmedetomidine and Ketamine as adjuvants in supraclavicular block in orthopedic surgery of the forearm in reducing postoperative pain
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 102 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is a randomized and double-blind clinical trial with the study of the structure of repeated measurements in 2024 in Razi Hospital Ahvaz, after obtaining permission from the Ethics Committee of Jundishapor University of Medical Sciences, Ahvaz, on 102 patients who are candidates for orthopedic surgery in the forearm region with informed consent. This study will be conducted in a double-blind manner, and in order to double-blind the study, the questionnaire will be recorded by another person who does not know about the drugs prescribed to the patient. Also, the attending physician will not have any information about how people are placed in the studied groups
Participants/Inclusion and exclusion criteria
Inclusion criteria;
Consent to participate in the study
Age range from 18 to 60 years
ASA class 1 and ASA class 2
Exclusion criteria;
Absence or withdrawal of consent, coagulation disorders, abuse of narcotics and sedatives, drug reaction to studied drugs, change of anesthesia method during surgery
Intervention groups
Recipients of dexmedetomidine and ketamine compared to placebo
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240512061761N1
Registration date:2024-05-26, 1403/03/06
Registration timing:prospective
Last update:2024-05-26, 1403/03/06
Update count:0
Registration date
2024-05-26, 1403/03/06
Registrant information
Name
nadia zergani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3444 4800
Email address
nadia.zergani71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Dexmedetomidine and Ketamine as adjuvants in supraclavicular block in orthopedic surgery of the forearm in reducing postoperative pain
Public title
Investigating the effect of Dexmedetomidine and Ketamine as Adjuvants in Supraclavicular block in orthopedic surgery of the forearm in reducing postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Age range from 18 to 60 years
ASA class 1و ASA class 2
Exclusion criteria:
Absence or withdrawal of consent
Coagulation disorders
Abuse of drugs and sedatives
Drug reaction to study drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into three groups based on the case number. At the beginning of the patients' visit for the procedure, a written consent form is obtained from the patients to enter the study, and the medical history of the patients is collected using the information in the medical records
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner, and in order to double-blind the study, the questionnaire will be recorded by another person who does not know about the drugs prescribed to the patient. Also, the attending physician will not have any information about how people are placed in the studied groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
No 50,, Azadegan Ave, Imam Khomeini Hospital, Pain Research Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6164643818
Approval date
2024-03-02, 1402/12/12
Ethics committee reference number
IR.AJUMS.REC.1402.676
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain
Timepoint
Examination is done at 1, 2, 6, 12 and 24 hours after the operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
Examination is done at 1, 2, 6, 12 and 24 hours after the operation
Method of measurement
Measuring with barometer and monitoring
Intervention groups
1
Description
Intervention group:Ketamine drug receiving group
Category
Treatment - Drugs
2
Description
Control group:Dexmedetomidine drug receiving group
Category
Treatment - Drugs
3
Description
Control group: placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Artadokht Khoshoui
Street address
No 50, Azadegan Ave, Imam Khomeini Hospital , Pain Research Center, Ahvaz
City
َAhvaz
Province
Khouzestan
Postal code
6164643818
Phone
+98 61 3444 4800
Email
adkh1489@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnosh Zakerkish
Street address
University city, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
itc@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
Artadokht Khoshoui
Position
Specialist doctor, faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 50, Azadegan Ave, Imam Khomeini Hospital, Pain Research Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6164643818
Phone
+98 61 3444 4800
Email
adkh1489@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Artadokht Khoshoui
Position
Specialist doctor, faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 50, Azadegan Avet, Imam Khomeini Hospital, pain Research Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6164643818
Phone
+98 61 3444 4800
Email
adkh1489@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Artadokht Khoshoui
Position
Specialist doctor, faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 50, Azadegan Ave, Imam Khomeini hospital, Pain Research Center, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6164643818
Phone
+98 61 3444 4800
Email
adkh1489@gmail.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 the end of the study and the end of the plan, all the information can be obtained through the research assistant of the university
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in other studies
From where data/document is obtainable
Applicants who send emails to the university's research assistant unit to conduct similar research
What processes are involved for a request to access data/document
Sending an email to the Research Vice-Chancellor of the Faculty, sending work methods and requesting information