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Analgesic effects of subcutaneous of low dose Ketamine before and after cesarean section surgery

Protocol summary

Summary
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 done in both groups equally. Inclusion criteria: - The patient's satisfaction – Age between 20 and 40 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 - Contraindication of Ketamine - 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 three groups according to table of random numbers. Groups "one", "two", and "three" will receive 0.5 mg/kg of ketamine with 10 ml Normal Saline Before surgery incision in place of incision Subcutaneously, 0.5 mg/kg of ketamine with 10 ml Normal Saline after end of surgery in place of incision Subcutaneously, and 10 ml Normal Saline after end of surgery in place of incision Subcutaneously, respectively. Postoperative pain and needs for analgesics will measured at 1,2,4,6,12,18 and 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022012539N1
Registration date: 2013-08-17, 1392/05/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-08-17, 1392/05/26
Registrant information
Name
Mehdi Aslani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0198
Email address
aslani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effects of subcutaneous of low dose Ketamine before and after cesarean section surgery
Public title
Analgesic effects of subcutaneous of low dose Ketamine before and after cesarean section surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: - The patient's satisfaction – Age between 20 and 40 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 - Contraindication of Ketamine - 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 40 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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No.12, Chamber Sadaf, Golestan Blvd
City
Ahvaz
Postal code
6135733777
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
ETH-641

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
1,2,4,6,12,18 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-Ketamine: Dose: 0.5mg/kg Number of using: Once Factory name: Rotex medica Manufacturing Country's Name: Germany Location prescribed: In place of incision Subcutaneously Administration time: Before surgery incision 2- Normal Saline: Dose: 10 ml Number of using: Once Factory name: Daroupakhsh Manufacturing Country's Name: Iran Location prescribed: In place of incision Subcutaneously Administration time: Before surgery incision
Category
Treatment - Drugs

2

Description
Drugs: 1-Ketamine: Dose: 0.5mg/kg Number of using: Once Factory name: Rotex medica Manufacturing Country's Name: Germany Location prescribed: In place of incision Subcutaneously Administration time: After end of surgery 2- Normal Saline: Dose: 10 ml Number of using: Once Factory name: Daroupakhsh Manufacturing Country's Name: Iran Location prescribed: In place of incision Subcutaneously Administration time: After end of surgery
Category
Treatment - Drugs

3

Description
Drug: Normal Saline Dose: 10 ml Number of using: Once Factory name: Daroupakhsh Manufacturing Country's Name: Iran Location prescribed: In place of incision Subcutaneously Administration time: After end of surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Educational Hospital
Full name of responsible person
Dr. Kaveh Behaeen
Street address
No. 307, Kokab Street, Masters Alley, Golestan Blvd.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
No. 21, Ave. 1, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Aslani
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd
City
Ahvaz
Postal code
6135786955
Phone
+98 61 1332 5869
Fax
+98 86113325478
Email
aslani.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Aslani
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd
City
Ahvaz
Postal code
6135786955
Phone
+98 61 1332 5869
Fax
+98 86113325478
Email
aslani.m@ajums.ac.irfatahi.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehdi Aslani
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
No. 12, Enghelab Chamber, Golestan Blvd.
City
Ahvaz
Postal code
6135786955
Phone
+98 61 1332 5869
Fax
+98 61 1332 5869
Email
aslani.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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