In this study we aim to compare the effect of Tramadol Versus Bupivacain in the cesarean section incision painl. and their complications such as: respiratory depression, nausea and vomiting will be compared too. Ninety eight pregnant women in the ASA class I& II, who are candidate for elective cesarean section under general anesthesia will be recruited in this study, they will be allocated randomly according to simple randomization into two groups: 49 patients in the Tramadol group and 49 patients in the Bupivacain group. Patients with history of cardiopulmonary disorders; Allergic reaction to drugs use in study; Alcohol addiction; addiction to opium or other illicit drugs; Chronic pain syndrome; Convulsion will be excluded. In the first group, before surgical incision 20 ml of Bupivacain 0.25% will be injected in the site of incision by surgeon who is not aware of drug used in the study. In the second group, before surgical incision 2mg/Kg Tramadol in total volume of 20 ml of is injected in the site of incision. Then pain intensity of patients will be recorded by educated nurse with visual analogue scale(VAS) in recovery room and ward every one hour till 24 hours and will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070111662N2
Registration date:2013-09-07, 1392/06/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pre-incisional Local Infiltration of Tramadol Versus Bupivacaine For Postoperative Pain Control in Elective Cesarean Section surgery
Public title
painless effect of the injected tramadol in the Cesarean Section incision
Purpose
Prevention
Inclusion/Exclusion criteria
About 98 females who will candidate for elective cesarean section under general anesthesia wil bel enrolled in this study.
Exclusion criteria: Emergency surgery; Cardiopulmonary disorders; Allergic reaction to drugs use in study; Alcohol addiction; Addiction to opium or other illicit drugs; Chronic pain syndrome; Convulsion.
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:
49
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
Shiraz University Medical Research Ethic Committee
Street address
Shiraz University of Medical Sciences ,Zand Blv
City
Shiraz
Postal code
197871345
Approval date
2013-04-25, 1392/02/05
Ethics committee reference number
CT-P-92-3976
Health conditions studied
1
Description of health condition studied
Postoperative Pain
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
Postoperative pain intensity
Timepoint
Every one hour in the first postoperative 24 hr
Method of measurement
Visual Anlouge Scale
Secondary outcomes
1
Description
Respiratory depression
Timepoint
Every one hour during first postoperative 24 hr
Method of measurement
Respiratory depression is defined as respiratory rate less than 8 per min
2
Description
Nausea and Vomiting
Timepoint
Every one hour during first postoperative 24 hr
Method of measurement
Nausea is defined as urge to vomiting without ejection ofof the contents of the stomach through the mouth, Vomiting is defined asto eject of the contents of the stomach through the mouth, usually in a series of involuntary spasmic movements.
Intervention groups
1
Description
In the group A, at the begining of surgery,before surgical incision 20 ml of bupivacain 0.25% is injected in the site of incision by surgeon who is not aware of drug used in the study.
Category
Treatment - Drugs
2
Description
In the group B, at the begining of surgery,before surgical incision 2mg/Kg tramadol in total volume of 20 ml of is injected in the site of incision by surgeon who is not aware of drug used in the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Training and Medical Center
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Hafez Training and Medical Center,Chamran Blv
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Vice-Chancellery of Research and Technology Department, 7th floor,Shiraz University Of Medical Sciences building
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
71937 11351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
71937 11351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Namazi Sq, Namazi Hospital, Shiraz Anesthesiologyand Critical Care Research Center
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)