The objective of this study was to assess the effect of subcutaneous Dexamethasone added to Bupivacaine on post cesarean pain control. 75 pregnant women were randomly assigned to receive following interventions at the time of skin closure, A) Bupivacaine 20 ml, 0.25% (SC) + Dexamethasone 4 ml (16 mg) (SC) + Normal saline 4 ml iv B) Bupivacaine 20 ml, 0.25%(SC) + Dexamethasone 4 ml (16 mg) IV + Normal saline 4 ml iv C) Bupivacaine 20 ml, 0.25% (SC) + normal saline 4 ml SC + normal saline 4 ml IV (placebo group). Pain intensity, systolic and diastolic blood pressure, heart rate and opioid consumption were evaluated at the recovery room, 6, 12, 24, 48 and 72 hours postoperatively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809242405N3
Registration date:2010-01-20, 1388/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-20, 1388/10/30
Registrant information
Name
Mitra Jabalameli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7472
Email address
jabalameli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-07-29, 1387/05/08
Expected recruitment end date
2009-10-10, 1388/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Subcutaneous Dexamethasone Added to Bupivacaine on Postcesarean Pain Relief
Public title
Evaluating the Effect of Subcutaneous Dexamethasone Added to Bupivacaine on Postcesarean Pain Relief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients, ASA physical status I-II, scheduled for elective cesarean section, under general anesthesia.
Exclusion Criteria: patients with suspected or manifest bleeding disturbances, allergy to Bupivacaine or Dexamethasone, atopia, diabetes mellitus, the presence of liver or kidney diseases, abuse of drugs and patients with pregnant induced hypertension or preeclampsia.
Age
From 16 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research Brueae, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2007-04-21, 1386/02/01
Ethics committee reference number
385552
Health conditions studied
1
Description of health condition studied
Complications of anaesthesia during pregnancy
ICD-10 code
O29.8
ICD-10 code description
Other complications of anaesthesia during pregnancy