The purpose of this study was to evaluate the effects of tramadol vs bupivacaine administration at wound closure on postoperative pain relief in patients undergoing cesarean section (CS). Sixty women undergoing cesarean deliveries were randomly assigned to receive either 10ml of bupivacaine 0.5% (n=30) or 50mg tramadol in 10ml normal saline ( n=30 ) both as a local wound infiltration prior to skin closure at the end of operation. Postoperative pain is evaluated with a visual analogue scale (VAS: 0-10) at 1, 2 and 6 hours after operation. Time to first analgesic administration, analgesic consumption in the 24hours after operation is recorded and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204132963N9
Registration date:2012-04-18, 1391/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-04-14, 1390/01/25
Expected recruitment end date
2012-03-15, 1390/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative analgesic effect of subcutaneous administration of tramadol or bupivacaine in the incision of cesarean section.
Public title
Comparison of postoperative analgesic effect of subcutaneous administration of two drugs in the incision of cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :patients with term pregnancy and normal fetus ,in range of 18-35yr,60-90kg,and no underline disease who are candidate for cesarean section.
Exclusion criteria:cardio-pulmonary disease, diabetes, hypertention, preeclampsia, previous history of addiction.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-04-12, 1390/01/23
Ethics committee reference number
38523
Health conditions studied
1
Description of health condition studied
postoperative abdominal pain
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
postoperative pain
Timepoint
1,2 and 6 hours postoperatively
Method of measurement
visual analog pain score
Secondary outcomes
1
Description
the first request of the patient for analgesic
Timepoint
during 24 hours after operation
Method of measurement
in hours
2
Description
opioid consumption
Timepoint
during 24 hours after operation
Method of measurement
mg morphine
3
Description
Drug side effects
Timepoint
during 24 hours after the operation
Method of measurement
asking the patient
Intervention groups
1
Description
subcutaneous administration of 10ml of bupivacaine 0.5% as a local wound infiltration prior to skin closure at the end of operation
Category
Treatment - Drugs
2
Description
subcutaneous administration of 50mg tramadol in 10ml normal saline as a local wound infiltration prior to skin closure at the end of operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)