Comparison of fentanyl and magnesium sulfate intrathecal and intraarticular in pain after knee arthroscopy
Design
The study will be double blind and clinical trial.140 patients will be randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients With knee arthroscopyin Valiasr Hospital in Arak are divided into 4 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 60 years old, ASA class 1 and 2, no history of drug use, no history of chronic painkiller use, no allergy to the drugs used, no liver and kidney failure, absence of body mass index greater than 30, absence of cardiovascular problems and arrhythmia, absence of peripheral and central neuropathy, absence of local infection in the spinal area
Exclusion criteria: patient's lack of consent to continue participating in the study, patient's refusal to perform spinal anesthesia, failure to perform spinal anesthesia
Intervention groups
Intervention group 1: 100 mg magnesium sulfate without preservative along with 15 mg bupivacaine 0.5% hyperbaric.
Intervention group 2: 8 ml of 10% magnesium sulfate with 12 ml of distilled water and a total volume of 20 ml is administered intra-articularly.
Intervention group: 50 micrograms of fentanyl along with 15 mg bupivacaine 0.5% hyperbar (heavy) will be
Intervention group 4: 50 micrograms of fentanyl will be added to 19 ml of normal saline.
Main outcome variables
Pain-average analgesic drug consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N181
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fentanyl and magnesium sulfate intrathecal and intraarticular in pain after knee arthroscopy
Public title
Comparison of fentanyl and magnesium sulfate intrathecal and intraarticular in pain after knee arthroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years
both sexes
ASA class 1 and 2
No history of drug use
No history of chronic use of painkillers
Lack of sensitivity to the drugs used in this study
Absence of liver and kidney failure
Absence of underlying disease such as high blood pressure, diabetes, history of infection and malignancy, coagulation diseases
Candidate patients for knee arthroscopy
Absence of body mass index greater than 30
Absence of cardiovascular problems and arrhythmia
Lack of psychological problems
Absence of peripheral and central neuropathy
Absence of local infection in the spinal area
Exclusion criteria:
The patient's lack of consent to continue participating in the study
The patient's refusal to perform spinal anesthesia
Failure to perform spinal anesthesia
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 4 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to make the study double-blind, the data are measured, reviewed and recorded by an intern who is unaware of the groupings, and the preparation of drugs in each group is done by an anesthetist and used during surgery. The patient does not know about the grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.ARAKMU.REC.1401.281
Health conditions studied
1
Description of health condition studied
knee arthroscopy
ICD-10 code
T84.042D
ICD-10 code description
Periprosthetic fracture around internal prosthetic right knee joint, subsequent encounter
Primary outcomes
1
Description
Pain
Timepoint
Recovery and 1, 6, 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Average analgesic drug consumption
Timepoint
End of study
Method of measurement
Hospital file
Secondary outcomes
empty
Intervention groups
1
Description
. Intervention group 1: 100 milligeram magnesium sulfate without preservative (magnesium sulfate used will be 10% and manufactured by Pasteur Institute pharmaceutical company, Tehran-Iran) along with 15 milligeram bupivacaine 0.5% hyperbaric.
Category
Treatment - Drugs
2
Description
Intervention group 2: 8 millileter of 10% magnesium sulfate with 12 millileter of distilled water and a total volume of 20 millileter is administered intra-articularly.
Category
Treatment - Drugs
3
Description
Intervention group 3: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) along with 15 mg bupivacaine 0.5% hyperbar (heavy) manufactured by Strazenka Company (Cambridge - England) imported by Kobel Daru Company (Tehran - Iran) will be.
Category
Treatment - Drugs
4
Description
Intervention group 4: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) will be added to 19 ml of normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Hesamedin Modir
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
salehi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Sosanabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
sosanabadi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street