After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done among patients with Elective Cesarean Section. Spinal anesthesia with 12.5 mg Marcaine will do in both groups equally. Inclusion criteria: - The patient's satisfaction – Age between 18 and 30 years old - ASA class I & II. Exclusion criteria: - The lack of patient's satisfaction to spinal anesthesia - History of hypnotics or narcotics throughout 24 hours before the surgery - History of drug abuse, or alcohol dependency -Contraindications of Spinal Anesthesia (Patient refusal; Infection at the site of planned needle puncture; Elevated intracranial pressure and Bleeding diathesis). Patients will be randomly allocated into two groups according to table of random numbers. Groups "one", and "two" will receive 100 mg of Teramadol with 8 mg Dexamethasone After end of surgery intravenously, 100 mg of Teramadol intravenously with 75 mg Diclofenac intramuscularly after end of surgery, respectively. Postoperative pain and needs for analgesics will measure at 2, 4, 8,12,8 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070718392N1
Registration date:2014-07-19, 1393/04/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Shaghayegh Mousavian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
mousavian.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Intravenous tramadol with Dexamethasone and tramadol with diclofenac on acute post-operative pain after cesarean surgery
Public title
Comparison of the effect of Intravenous tramadol with Dexamethasone and tramadol with diclofenac on acute post-operative pain after cesarean surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: - The patient's satisfaction – Age between 18 and 30 years old - ASA class I & II Exclusion criteria: - The lack of patient's satisfaction to spinal anesthesia - History of hypnotics or narcotics throughout 24 hours before the surgery - History of drug abuse, or alcohol dependency - Contraindications of Spinal Anesthesia( Patient refusal ; Infection at the site of planned needle puncture ; Elevated intracranial pressure and Bleeding diathesis)
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Postal code
6135733777
Approval date
2014-01-11, 1392/10/21
Ethics committee reference number
Ajums.REC.1392.241
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain
Timepoint
2,4,8,12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
24 hours after surgery
Method of measurement
Milligram
Intervention groups
1
Description
Drugs:
1-Teramadol:
Dose: 100 mg
Number of using: Once
Factory name: Alborz Darou
Manufacturing Country's Name: Iran
Location prescribed: Intravenous
Administration time: After end of surgery
2- Dexamethasone:
Dose: 8 mg
Number of using: Once
Factory name: Daroupakhsh
Manufacturing Country's Name: Iran
Location prescribed: Intravenous
Administration time: After end of surgery
Category
Treatment - Drugs
2
Description
Drugs:
1-Teramadol:
Dose: 100 mg
Number of using: Once
Factory name: Alborz Darou
Manufacturing Country's Name: Iran
Location prescribed: Intravenous
Administration time: After end of surgery
2- Diclofenac:
Dose: 75 mg
Number of using: Once
Factory name: Daroupakhsh
Manufacturing Country's Name: Iran
Location prescribed: Intramuscular
Administration time: After end of surgery