Determination of analgesia after spinal anesthesia with fentanyl and pethidine in femur and tibia fracture surgery
Design
The clinical trial has 3 groups, with factorial groups (including group 1: the group receiving fentanyl at a dose of 25 gm along with bupivacaine at a dose of 12-15 mg as a spinal injection, group 2: the group receiving pethidine 10 mg at a dose along with bupivacaine at a dose of 12 -15 mg as spinal injection and group 3: control group as bupivacaine 12-15 mg as spinal injection), double blind, randomized, phase 3 on 105 patients. Using a computerized randomization table, people are assigned to three groups.
Settings and conduct
Place of the project: Department of Orthopedic Operating Room of Bahonar Hospital, Kerman, drugs will be given as intraspinal injection. Patients will be blind. Medicines are given by the anesthesiologist and the anesthesiologist, and the researcher will not be aware of the treatment protocol. Therefore, two strains are considered blind.
Participants/Inclusion and exclusion criteria
1. Not drugs abuse
2. No history of sensitivity or adverse reaction to fentanyl or pethidine or known sensitivity to local anesthetics
3. Having an indication for spinal anesthesia
4. Not suffering from kidney and liver diseases
5. Absence of anatomical abnormalities at the injection site
Intervention groups
Group 1: The group receiving fentanyl at a dose of 25 gm along with bupivacaine at a dose of 12-15 mg as a spinal injection.
Group 2: The group receiving pethidine 10mg with a dose of bupivacaine with a dose of 12-15mg as a spinal injection.
Group 3: control group receiving bupivacaine 12-15mg spinal injection
Main outcome variables
pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240415061490N1
Registration date:2024-05-06, 1403/02/17
Registration timing:prospective
Last update:2024-05-06, 1403/02/17
Update count:0
Registration date
2024-05-06, 1403/02/17
Registrant information
Name
Amir Moshrefi zarandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
amirmoshrefi001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studing analgesia after spinal anesthesia with fentanyl and pethidine in femur and tibia fracture surgeries
Public title
Investigating analgesia after lumbar anesthesia with narcotic drugs in thigh and leg surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate for femur or tibia fracture surgery
Having an indication for spinal anesthesia
Exclusion criteria:
history of hypersensitivity or adverse reaction to fentanyl or pethidine or known hypersensitivity to local anesthetics
anatomical abnormalities at the injection site
drug abuse
kidney and liver diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done as available until the desired sample volume is reached, patients are randomized to receive fentanyl or pethidine in combination with bepivacaine or the control group before surgery using a computerized randomization table (Excel). For this, each patient receives a unique identification number and then these numbers are entered in the software and randomly assigned to one of the treatment groups. This randomization process is designed to ensure that each patient has an equal chance of being assigned to either group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the research doctor and the patient are blinded. The drugs are prepared by an anesthesiology nurse and injected by an anesthesiologist
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Afzalipur Hospital - Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.KMU.AH.REC.1402.205
Health conditions studied
1
Description of health condition studied
Fracture of femur
ICD-10 code
S72
ICD-10 code description
Fracture of femur
2
Description of health condition studied
Tibia fracture
ICD-10 code
S82.1
ICD-10 code description
Fracture of upper end of tibia
Primary outcomes
1
Description
pain score
Timepoint
in 2, 6, 12 and 24 hours after surgery
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
The time of the first housing application
Timepoint
The first 24 hours
Method of measurement
hours
2
Description
Total consumer pain killer
Timepoint
The first 24 hours
Method of measurement
File
3
Description
side effects
Timepoint
The first 24 hours
Method of measurement
File
Intervention groups
1
Description
Intervention group: the group receiving fentanyl at a dose of 25 μg along with bupivacaine at a dose of 12-15 mg as a spinal injection.
Category
Treatment - Drugs
2
Description
Intervention group: The group receiving pethidine 10 mg with a dose of bupivacaine with a dose of 12-15 mg as a spinal injection.
Category
Treatment - Drugs
3
Description
Control group: The control group receiving bupivacaine 12-15mg as a spinal injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahoner Hospital, Kerman
Full name of responsible person
Amir Reza Sadeghi Far
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Ebn-e-Sina St.,Jahad Blvd., The Vice Chancellor for Research
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amir Moshrefi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Gharani street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
amirmoshrefi001@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Jafar Salehi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Qarani St., Bahnar Hospital
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Dr.jsalehi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amir Moshrefi zarandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Gharani street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
amirmoshrefi001@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
At the end of the study, a part of the information including the effect of analgesia after spinal anesthesia with fentanyl and pethidine in femur and tibia fracture surgeries, after de-identifying people, will be shared with those interested in the health field.
When the data will become available and for how long
2 to 6 months after data analysis
To whom data/document is available
Health researchers, Medical doctors and Health workers
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Amir Moshrefi - Email
What processes are involved for a request to access data/document
The reason for access to the data - request to e-mail - will be sent within a month after checking the correctness of the request.