In this trail, we compare analgesic anesthetic and effect of tramadol and lidicaine for cesarean section. 60 patients with complete healthy condition; 1st and 2nd elective cesarean section; age between 18-45; without sensitivity to study drugs and opium addiction included the study. in group 1, surgeon will infiltrate bupivacaine 2 mg/kg subcutaneusely immediately after cesarean. in group 2, surgeon will infiltrate tramadol 2 mg/kg subcutaneusely immediately after cesarean. We assessed postoperative pain, 1,2,3 hours after cesareanusing visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106203468N8
Registration date:2011-09-22, 1390/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Mohammad Reza Hajiesmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983516227747-00983517232422
Email address
hajiesmaeili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pain Research Center, Shahid Sadoughi University of Medical Science and Health Services, Yazd, Iran
Expected recruitment start date
1990-02-01, 1368/11/12
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative analgesic effect of tramadol with bupivacaine for cesarean section
Public title
Postoperative analgesic effect of tramadol and bupivacaine for cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: complete health condition; first or second time elective cesarean section candidate; age between 18-45 years.
Exclusion criteria: sensitivity to study drugs; opium addiction
Age
From 18 years old to 45 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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science and Health Services
Street address
Shahid Bahonar Squire-Yazd-Iran
City
Yazd
Postal code
8919895746
Approval date
2011-08-03, 1390/05/12
Ethics committee reference number
پ/17/1/57202
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
postoperative pain
Timepoint
1,2,3 hours after cesarean
Method of measurement
visual analogue scale
2
Description
time to first analgesic request
Timepoint
time between intervention and first analgesic administratin
Method of measurement
minutes
3
Description
total analgesic consumption
Timepoint
24 after intervention
Method of measurement
mg/kg consumped meperidine
Secondary outcomes
1
Description
side effects
Timepoint
24 hours after intervention
Method of measurement
observation
Intervention groups
1
Description
in group 1, surgeon will infiltrate bupivacaine 2 mg/kg subcutaneusely immediately after cesarean.
Category
Other
2
Description
in group 2, surgeon will infiltrate tramadol 2 mg/kg subcutaneusely immediately after cesarean.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khatami Hospital
Full name of responsible person
Dr Atiyeh Gavaheri
Street address
City
Herat
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pain Research Center
Full name of responsible person
Dr Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pain Research Center
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
Ayatollah Khatami Hospital
Full name of responsible person
Dr Atiyeh Gavaheri
Position
Gynecologist
Other areas of specialty/work
Street address
Ayatollah Khatami Hospital
City
Herat
Postal code
Phone
+98 35 2572 1401
Fax
Email
atiyeh56@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Dr Mohammad Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon Hospital
City
Yazd
Postal code
8919895746
Phone
+98 35 1626 8111
Fax
+98 35 1622 7747
Email
hajiesmaeili@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran
Full name of responsible person
Dr Mohammad Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon Hospital
City
Yazd
Postal code
8919895746
Phone
+98 35 1622 7747
Fax
+98 35 1622 7747
Email
hajiesmaeili@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)