A clinical trial to compare the effectiveness of bupivacaine along with dexmedetomidine with bupivacaine on adductor canal block after unilateral total knee arthroplasty
To compare the effectiveness of bupivacaine along with dexmedetomidine with bupivacaine on adductor canal block after unilateral total knee arthroplasty
Design
A randomized and double-blind clinical trial with parallel and control groups will be conducted on 48 patients using random number tables.
Settings and conduct
Patients candidate for unilateral total knee arthroplasty referring to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the bupivacaine along with dexmedetomidine and control will receive bupivacaine after surgery. The participants and responsible for data collection are blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for unilateral total knee arthroplasty; age over 18 years.
Exclusion criteria: Having a contraindication for adductor canal block; having diabetes mellitus; having local anesthetics allergies; bradycardia; long-term use of analgesics; having liver failure; having renal failure.
Intervention groups
The intervention group will receive 15 mg bupivacaine 0.5% along with 1 mg/kg dexmedetomidine to adductor canal block after unilateral total knee arthroplasty. The control group will receive 15 mg bupivacaine 0.5% and 1 mg/kg fentanyl to adductor canal block after unilateral total knee arthroplasty.
Main outcome variables
Evaluation the rate of pain, prescribing the first pain reliever after surgery, the rate of pain reliever consumption and 100-step walking test time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230215057432N1
Registration date:2023-02-21, 1401/12/02
Registration timing:prospective
Last update:2023-02-21, 1401/12/02
Update count:0
Registration date
2023-02-21, 1401/12/02
Registrant information
Name
Hossein Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
khademihs1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of bupivacaine along with dexmedetomidine with bupivacaine on adductor canal block after unilateral total knee arthroplasty
Public title
The effectiveness of dexmedetomidine on pain relief after unilateral total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for unilateral total knee arthroplasty
Age over 18 years
Exclusion criteria:
Having a contraindication for adductor canal block
Having diabetes mellitus
Having local anesthetics allergies
Bradycardia
Long-term use of analgesics
Having liver failure
Having renal failure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be simple randomly assigned to intervention groups using a random table type and opaque envelopes will be used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and responsible for data collection are blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2022-10-11, 1401/07/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.618
Health conditions studied
1
Description of health condition studied
Unilateral total knee arthroplasty
ICD-10 code
Z96.6
ICD-10 code description
Presence of orthopaedic joint implants
Primary outcomes
1
Description
The rate of pain
Timepoint
1, 3, 6, 12, 18 and 24 hours after intervention
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
1
Description
The rate of pain reliever consumption
Timepoint
24 hours after intervention
Method of measurement
Type and amount of pain reliever consumed by the patient
2
Description
Prescribing the first pain reliever after surgery
Timepoint
After intervention
Method of measurement
Based on minutes after surgery
3
Description
100-step walking test time
Timepoint
Before, one and two days after intervention
Method of measurement
Based on minutes
Intervention groups
1
Description
Intervention group: The intervention group will receive 15 mg bupivacaine 0.5% (Darou Darman Pars, Iran) along with 1 mg/kg dexmedetomidine (Darou Darman Arang, Iran) to adductor canal block after unilateral total knee arthroplasty.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive 15 mg bupivacaine 0.5% (Darou Darman Pars, Iran) and 1 mg/kg fentanyl (Caspian Tamin, Iran) to adductor canal block after unilateral total knee arthroplasty.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Sharafi
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Sharafim991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Sharafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Sharafim991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Sharafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Sharafim991@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Sharafi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Sharafim991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Maryam Sharafi provides the data analysis to the applicants via email: Sharafim991@mums.ac.ir.
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.