Clinical trials of the Effect of intrathecal Magnesium Sulfate on duration of analgesia after cesarean section, with spinal anesthesia, compared with patients undergo a normal routine
The aim of this study is to evaluate intrathecal effect of sulfate magnesium on the duration of analgesia. The study population includes all women admitted to Jahrom Peymanieh hospital for Caesarean Section with spinal anesthesia and do not have exclusion criteria. The sample size is estimated to be 69 people. Before surgery, women divided into three groups with throwing dice: a control group and two intervention groups. In the control group (I), 2 ml Marcaine 0.5% and 0.8 mL of normal saline was injected into the mother. In the intervention group (II), the mother received 2 ml Marcaine 0.5% plus 50 mg (0.5 mL) sulfate magnesium with 0.3 ml normal saline. In the intervention group (III) 2 ml of Marcaine 0.5% plus 80 mg (0.8 mL) sulfate magnesium was injected to the mother. From time of Su-Mg injection until the time that the patient experiences the pain for the first time, duration of analgesia was recorded. In order to prevent complications sulfate magnesium injection, the mothers were monitored for 48 hours. All women should give their informed consent for the study. Addicted patients or those who are long-term user of narcotics or painkillers, those suffering from unstable hemodynamic condition, the change of spinal anesthesia to general anesthesia and those who lack mental health were excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101914049N4
Registration date:2017-02-08, 1395/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-08, 1395/11/20
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Jahrom University of Medical Sciences
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2016-10-04, 1395/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of the Effect of intrathecal Magnesium Sulfate on duration of analgesia after cesarean section, with spinal anesthesia, compared with patients undergo a normal routine
Public title
The Effect of intrathecal Magnesium Sulfate on duration of analgesia after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the patients who are going to do cesarean section at Motahari hospital affiliated to Jahrom University of Medical Sciences, can receive spinal anesthesia, Informed consent for participation in this study. Exclusion criteria: education under primary school, chronic pains and cancer, lack of mental and psychological health, chronic use of painkillers and narcotics, Unstable hemodynamic status, expressing disagreement for continuing the research.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
For blinding in the present study, a double-blind method is used in a way that (1) the person who reviews the results and (2) the person who performs the injections are unaware of which patients did not received sulfate magnesium and which ones did not have any distilled water
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of medicine, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Approval date
empty
Ethics committee reference number
jums.REC.1392.069
Health conditions studied
1
Description of health condition studied
Scores Pain after injection of sulfate magnesium
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
duration of analgesia after injection of sulfate magnesium
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
duration of analgesia
Timepoint
The first time of pain by mother
Method of measurement
According to time
Secondary outcomes
1
Description
Vital Signs
Timepoint
Every 4 hours after surgery Within 48 hours(2 days)
Method of measurement
Monitoring Blood pressure, Heart Rate, Breathing
Intervention groups
1
Description
Intervention group: In the first intervention group, the patient received 2 cc Bupivacaine 0.5%+ 0.3 cc normal saline+0.5 cc magnesium sulfate 10% (group M50) at the beginning of surgery and after entering the maternity ward; the score of pain, duration of analgesia and Hemodynamic signs measured and recorded at mentioned time.
Category
Treatment - Drugs
2
Description
Control group: patients received 2 cc Bupivacaine 0.5%+ 0.8 cc normal saline at the same time with the start of surgery and their score of pain, duration of analgesia and Hemodynamic signs recorded after entering maternity ward.
Category
Placebo
3
Description
Intervention group: In the second intervention group, the patient received 2 cc Bupivacaine 0.5%+ 0.8 cc magnesium sulfate 10% (group M80) at the beginning of surgery and after entering the maternity ward; the score of pain, duration of analgesia and Hemodynamic signs measured and recorded at mentioned time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Farzaneh Mehran
Street address
Motahhari Blvd, Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Solh Ju Kavos
Street address
Vice chancellor for research, Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Farzaneh Mehran
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 3743 8517
Fax
Email
MehranFarzaneh711@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abbasi Jahromi Ali
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71564742546
Fax
Email
AbbasiJa@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Farzaneh Mehran
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 3743 8517
Fax
Email
MehranFarzaneh711@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)