Determination of the effect of adding magnesium sulfate to Marcaine intrathecal in post-operative cesarean section pain control
Design
Clinical trial, with control group, Draw randomization, 42 subjects, double blind
Settings and conduct
In this study, 42 pregnant women who were candidates for non-emergency cesarean section participated.Patients were randomly divided into two groups of intervention and control by lottery (n=21). This study will be conducted at Vali-e-Asr Hospital in Birjand.
This study was double blinded so that the surgeon and patient and technician would not be aware of the type of used solution.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women of 15-45 years old ; no history of postoperative bleeding ; no allergy to Amide anesthetics; no history of heart, liver, renal, infectious and coagulation diseases; no history of taking psychedelic drugs and smoking.
Exclusion criteria: Having neuro-muscular disease; Use of opioids or painkillers during 3 days before the study; Severe obesity (BMI ≥ 35-34); Consumption of calcium channel blockers
Intervention groups
Intervention group: Patients receive 10 mg Marcaine 0.5% (CobelDarou, Tehran) and 80 mg magnesium sulfate (CobelDarou, Tehran) intrathecally (in the third and fourth or fourth and fifth intervertebral space) .
Control group: Patients receive only 10 mg of intrathecal Marcaine 0.5% (CobelDarou, Tehran) intrathecally (in the third and fourth or fourth and fifth intervertebral space).
Main outcome variables
Pain, Blood pressure, Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190123042473N1
Registration date:2021-02-28, 1399/12/10
Registration timing:retrospective
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Mohammad Ebnehejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 0119
Email address
ebnehejazi49@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-05, 1396/11/16
Expected recruitment end date
2019-02-05, 1397/11/16
Actual recruitment start date
2018-02-05, 1396/11/16
Actual recruitment end date
2019-02-05, 1397/11/16
Trial completion date
2019-02-05, 1397/11/16
Scientific title
The effect of adding magnesium sulfate to Marcaine intrathecal in controlling pain after cesarean section
Public title
The effect of magnesium sulfate on post-cesarean pain control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women without history of bleeding after surgery.
Women without allergy to Amide anesthetics.
Women without history of heart, liver and renal diseases.
Women without history of taking psychedelic drugs.
The women with the age of 15 - 45 years.
The women without history of smoking.
The women without history of coagulation diseases.
The women without history of infectious diseases.
Exclusion criteria:
Having neuro-muscular disease
Use of opioids or painkillers during 3 days before the study
Severe obesity (BMI ≥ 35-34)
Consumption of calcium channel blockers
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method;
Eligible individuals were randomly assigned to one of the two groups of Marcaine intrathecal or magnesium sulfate recipients along with Marcaine intrathecal. The method of drawing was to place balls in container that the number of 1 to 9 was written inside the balls. For each patient who entered the study, a ball went out of the container accidentally. If the it was an odd number, that patient would be assigned to the Marcaine intrathecal group, and if it was even , the individual would be assigned to the magnesium sulfate receiving group, along with Marcaine intrathecal.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs of Marcaine intrathecal and magnesium sulfate recipients along with Marcaine intrathecal were prepared by a pharmacist with similar shape, color, smell, and size and placed in coded packages, and provided to the researcher. He/She prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of 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 Birjand University of Medical Sciences
Street address
Birjand University of Medical sciences, Ghafari Ave
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-02-11, 1396/11/22
Ethics committee reference number
ir.bums.REC.1396.320
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
O75.9
ICD-10 code description
Complication of labor and delivery
Primary outcomes
1
Description
Pain
Timepoint
at 1, 2, 3, 4, 8, 12 postoperative hours
Method of measurement
Verbal Analogue Scale method
2
Description
blood pressure
Timepoint
at 1, 2, 3, 4, 8, 12 postoperative hours
Method of measurement
Mercury sphygmomanometer
3
Description
hear rate
Timepoint
at 1, 2, 3, 4, 8, 12 postoperative hours
Method of measurement
heart-rate monitors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receives 10 mg of marcaine 0.5% (CobelDarou, Tehran) and 80 mg of magnesium sulfate (CobelDarou, Tehran) , intrathecally (in the third, fourth or fourth and fifth space between the vertebrae) before surgery. The severity of pain will be recorded using the VAS score and by asking the patient at 1, 2, 3, 4, and 8 hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive only 10 mg of marcaine 0.5% (CobelDarou, Tehran) intrathecally (in the third, fourth or fourth and fifth space between the vertebrae). The severity of pain will be recorded using the VAS and asking the patient at 1, 2, 3, 4, and 8 hours after surgery.