Investigating the effects of magnesium sulfate compared to placebo in controlling pain during the first 24 hours after cesarean delivery with spinal anesthesia in pregnant women, a double-blind study
Determining the effects of preventive and low doses of magnesium sulfate in controlling pain and headache after cesarean section
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 118 patients. Blocked randomization will be used.
Settings and conduct
The location of the study was the postpartum ward at Al-Zahra Hospital in Rasht city. The samples of this research include pregnant women. Blinding is a two-way blind method (double blind). So that the patients will not know about the group they are assigned to. The drug will be placed in the same vials in both groups. The allocation envelope will be provided to an anesthesiologist and they are requested to prepare the drugs according to the listed group and provide them to the second anesthesiologist who will be present during the surgery. None of the people present in the operating room, including gynecologists, anesthesiologists, gynecological assistants, and nurses, will know how to allocate people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cesarean section with spinal anesthesia; placement in anesthesia class II; being nulliparous; acceptable candidate for cesarean section.
Exclusion criteria: Magnesium intake 24 hours before surgery; History of any surgery; Suffering from kidney dysfunction; Suffering from heart dysfunction; Suffering from Lung dysfunction; Suffering from Liver dysfunction
Intervention groups
Intervention group: Patients in this group are treated with 50 mg/kg of magnesium sulfate in 100 cc of isotonic normal saline solution.
Control group: Patients in this group are treated with 100 cc isotonic normal saline solution.
Main outcome variables
The amount of pain In the abdominal surgery area; Headache; the need for painkillers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090525001946N11
Registration date:2024-01-02, 1402/10/12
Registration timing:prospective
Last update:2024-01-02, 1402/10/12
Update count:0
Registration date
2024-01-02, 1402/10/12
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of magnesium sulfate compared to placebo in controlling pain during the first 24 hours after cesarean delivery with spinal anesthesia in pregnant women, a double-blind study
Public title
The effects of magnesium sulfate in controlling pain and headache in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cesarean section with spinal anesthesia
Placement in class II of anesthesia
Being nuli para
Acceptable candidate for caesarean section
Exclusion criteria:
Magnesium intake 24 hours before surgery
History of any surgery
Suffering from kidney dysfunction
Suffering from heart dysfunction
Suffering from Lung dysfunction
Suffering from Liver dysfunction
Suffering from Myopathy dysfunction
Suffering from neuropathy dysfunction
Occurrence of severe preeclampsia symptoms
Occurrence of eclampsia symptoms
Having contraindications for spinal injection such as injection site infection
Having contraindications for spinal injection such as coagulation disorders
Severe obesity (BMI>30)
Treatment with calcium receptor blocking drugs
Drug addiction
History of long-term use of steroids
Allergy to magnesium
Multiple pregnancy
Age
From 9 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization method will be used. Patients are classified into two equal groups: magnesium (M) and placebo (p). For this reason, quadruple blocks will be used, which create six states: (1)MPPM. (2)MPMP. (3)MMPP. (4)PMMP. (5) PMPM. (6)PPMM .
We create random integers between 0 and 60 with the help of a computer.
For numbers between 0-10, we assign the first combination, for numbers 11-20, the second combination and...
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not know which group they are assigned to. The drug will be placed in the same vials in both groups. The allocation envelope will be provided to an anesthesiologist and
They are requested to prepare the drugs according to the listed group and provide them to the second anesthesiologist who will be present during the surgery. None of the people present in the operating room, including gynecologists, anesthesiologists, gynecological assistants, and nurses, will know how to allocate people.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan University of Medical Sciences
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.GUMS.REC.1401.413
Health conditions studied
1
Description of health condition studied
low and prophylactic doses magnesium sulfate on pain control
ICD-10 code
060-075
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
amount of pain in the abdominal surgery area
Timepoint
In the first 6, 12, 18, and 24 hours
Method of measurement
Pain with scores between zero and ten using a Numeric Pain Rating Scale
2
Description
amount of headache
Timepoint
At 6, 12, 18, and 24 hours on the first day and at 12 o'clock on the second and third day after the operation
Method of measurement
Using the headache scoring scale (Visual Analog Scale) with scores between 0 and 10
3
Description
The amount of painkillers used
Timepoint
In the first 6, 12, 18, and 24 hours
Method of measurement
If the postoperative VAS, NRS score is greater than three
Secondary outcomes
1
Description
Sensory block
Timepoint
30 seconds before the skin incision and then from the time the skin incision is made until the end of the surgery, every five minutes until the end of the sensory block.
Method of measurement
Using a short needle (pin prick test) for sensory block
2
Description
Motor block
Timepoint
30 seconds before the skin incision and then from the time the skin incision is made until the end of the surgery, every five minutes until the end of the sensory block
Method of measurement
Evaluation of motor block based on three questions of modified Bromage scale
Intervention groups
1
Description
Intervention group: 50 mg/kg of magnesium sulfate in 100 ml of isotonic normal saline solution produced by Pasteur Institute factory and the Iran Injection and Pharmaceutical Products Company will be given intravenously as a preventive dose, once, 15 minutes before the induction of spinal anesthesia.
Category
Prevention
2
Description
Control group: they will receive 100 ml isotonic normal saline solution produced by the Iran Injection and Pharmaceutical Products Company, intravenously, as a preventive dose, once 15 minutes before the induction of spinal anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Mandana Mansour Ghanaie
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3336 9224
Email
m_m_ghanaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramzar Farzan
Street address
Vice-chancellors for Research; front of 17-Shahrivar Hospital, Shahid Siadati street., Namjoo avenue
City
Rasht
Province
Guilan
Postal code
- 41446-66949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sedighe Bab Eghbal
Position
MSc in Health Education
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
Sedigheh.eghbal@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mandana Mansour Ghanaie
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839- 41446
Phone
+98 13 3336 9224
Email
m_m_ghanaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sedighe Bab Eghbal
Position
MSc in Health Education
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
Sedigheh.eghbal@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document