This triple blind clinical trial is conducted on 192 pregnant women who are admitted for elective cesarean section in Arak Thaleghani Hospital. After obtaining written consent, the patients are randomized and divided into two groups. Both groups undergo spinal anesthesia with 75 mg lidocaine 5%. During the operation, both groups are under standard monitoring. At the end of the surgery and before closing the wound, the intervention group is injected with a 20 ml mixture of 750 mg magnesium sulfate and normal saline locally at the site of operation and the control group receives only 20 ml of normal saline. After the surgery, all patients are followed at 4, 8, 12 and 24 hours for pain intensity by Visual Analog Scale and the amount of anti analgesic that is used during this period are calculated. For pain control in both groups, diclofenac suppositories are used and if the pain is not controlled or the VAS measurement is more than 5, meperidine 1 mg/kg intramuscular is administered. During this time all patients are observed for possible side effects such as hypo tension, dysrhythmia, diplopia, dyslexia and local pain and burning sensation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104303247N2
Registration date:2011-05-19, 1390/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-19, 1390/02/29
Registrant information
Name
Shirin Pazoki
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
pazooki.sh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate local injection in surgical incision for cesarean section postoperative pain control
Public title
the effect of magnesium sulfate injection in surgical incision for postoperative pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with anesthetic class ASA1 or 2 and age range of 20 -35 years, no history of: pre eclampsia , chronic hypertension, heart, liver, kidney and mental disorders, chronic opioid abuse, calcium channel blocker medications, and elective operations.
Exclusion criteria:
If the anesthetic level is not satisfactory and we have to give opioids or anesthetics during surgery or if magnesium sulfate has to be given generally for hypertensive postoperative patients
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Postal Box 646, Alam al hoda st., Shiroodi st.
City
Arak
Postal code
3819693345
Approval date
2010-01-27, 1388/11/07
Ethics committee reference number
88-74-3
Health conditions studied
1
Description of health condition studied
Acute postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Postoperative pain intensity
Timepoint
4, 8, 12 and 24 hours postoperatively
Method of measurement
Visual analog Scale
2
Description
Amount of diclofenac supposetories required
Timepoint
During first 24 hour postoperatively
Method of measurement
mg
3
Description
Amount of intramuscular pethidine required
Timepoint
24 hours postoperatively
Method of measurement
Mili gram (mg)
Secondary outcomes
1
Description
Possible side effects
Timepoint
During the first 24 hour postoperatively
Method of measurement
Patients medical records
Intervention groups
1
Description
Intervention group: at the end of surgery and before closing the wound 20 ml mixture of 750 mg magnesium sulfate and normal saline is injected locally in the operation site