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The Effect of Magnesium Sulphate on Postoperative Pain and Opioid Consumption in Total knee arthroplasty

Protocol summary

Study aim
The effect of injectable magnesium sulfate on pain and reducing the need for opioids after total knee arthroplasty
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients. Random allocation software was used for randomization.
Settings and conduct
Injection of magnesium sulfate into patients undergoing total knee arthroplasty
Participants/Inclusion and exclusion criteria
All individuals with a diagnosis of knee replacement surgery; Patients with diabetes, liver dysfunction, renal dysfunction, heart disorders, high blood pressure, neurological diseases, respiratory diseases, coagulation disorders, congenital diseases, pregnant women and mothers during breastfeeding, people taking calcium channel blockers, people who have received magnesium supplement in the last month before and during the study,people with serum magnesium above 2.8, sensitive people or contraindicated in fentanyl and Apotel
Intervention groups
1- The intervention group received 4 g of magnesium sulfate (equivalent to 8 cc of 50% magnesium sulfate) in 250 cc of normal saline by infusion 30 minutes before the operation, during the operation and up to 2 hours after the operation. 2 -The control group received 8 cc and 250 cc of normal saline (as an infusion with the same volume as the intervention group) 30 minutes before the operation, during the operation and up to 2 hours after the operation.
Main outcome variables
Measurement of patient pain with visual analogue scale and numerical rating scale at times immediately after surgery, 2, 4, 6, 12 and 24 hours after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161204031229N6
Registration date: 2022-03-23, 1401/01/03
Registration timing: retrospective

Last update: 2022-03-23, 1401/01/03
Update count: 0
Registration date
2022-03-23, 1401/01/03
Registrant information
Name
Azadeh Eshraghi
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy-International Campus, Iran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 86709
Email address
eshraghi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
2021-05-22, 1400/03/01
Actual recruitment end date
2021-07-23, 1400/05/01
Trial completion date
2021-08-23, 1400/06/01
Scientific title
The Effect of Magnesium Sulphate on Postoperative Pain and Opioid Consumption in Total knee arthroplasty
Public title
The effect of magnesium sulfate in reducing the pain of knee replacement surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All volunteers for Total knee arthroplasty
Exclusion criteria:
Diabetes Renal Disorder Hepatic Disorder Consumption of Calcium Blocker agents Consumption of Magnesium supplements before the study Consumption of Magnesium supplements during the study in the last month magnesium level more than 2.8 Pregnancy Lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 15 blocks to select 60 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively. Finally, group A receives control intervention and group B receives treatment intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is unaware that the medicine given to the patient is the main medicine or placebo. The participant (patient) is also unaware that the medicine being given to them is the main medicine or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
IR.IUMS.REC.1399.1067

Health conditions studied

1

Description of health condition studied
Total knee arthroplasty
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Evaluate the patient's pain
Timepoint
Immediately after surgery, 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Use visual analogue scale and numerical rating scale

2

Description
Serum level of magnesium sulfate
Timepoint
Daily
Method of measurement
Laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 4 g of magnesium sulfate (equivalent to 8 cc of 50% magnesium sulfate) in 250 cc of normal saline was infused 30 minutes before the operation, during the operation and up to 2 hours after the operation.
Category
Rehabilitation

2

Description
Control group: 8 cc and 250 cc normal saline (by infusion with the same volume as the magnesium group) were given 30 minutes before the operation, during the operation and up to 2 hours after the operation.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Mehdi Moghtadaei
Street address
Tehran, Sattar khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8670 2030
Email
mmoghtadaei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motevalian
Street address
Shahid Hemmat Gharb Highway - Between the Intersection of Sheikh Fazlullah Nouri and Shahid Chamran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2552
Fax
+98 21 8862 2703
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran - Sattar Khan - st. Prayer - Corner of Mansouri Street - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2564
Email
aepharm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran - Sattar Khan - st. Prayer - Corner of Mansouri Street - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2564
Email
aepharm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran - Sattar Khan - st. Prayer - Corner of Mansouri Street - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2564
Email
aepharm@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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The main consequence
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Total data
From where data/document is obtainable
Email: aepharm@gmail.com
What processes are involved for a request to access data/document
by Email
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