Purpose of Study: comparison the effect of morphine infusion withIV PCA and interathecal morphin in postop pain of tibia fracture. Study: randomized; double blind ; placebo; one central; phase II trial;
Inclusion criteria : age between 20 to 50 years old; ASA I,II.
Exclusion criterion: addiction to substance.
Interventoinal in study: in this study patient divided to two groups. The first group recevived spinal anesthesia with morphine and another group IV PCA with morphine. Time of interventions: the first Group in time of spinal and the second grop after spinal intravenous morphine using .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051513340N1
Registration date:2014-04-13, 1393/01/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-13, 1393/01/24
Registrant information
Name
Abolghasem Ahmadvand
Name of organization / entity
Qazvin University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 7006
Email address
aahmadvand@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Qazvin University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of morphine infusion with IV PCA and interathecal morphine in postop pain of tibia fracture
Public title
Comparision the effect of morphine infusion with IV PCA and interathecal morphine in postop pain of tibia fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age between 20 to 50 years old; ASA I,II.
Exclusion criterion: addiction to substance.
Age
From 20 years old to 50 years old
Gender
Both
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Of Qazvin University of Medical Science
Street address
Navab Avenue ; Qazvin University of Medical Science
City
Qazvin
Postal code
Approval date
2013-02-05, 1391/11/17
Ethics committee reference number
28/20/6889
Health conditions studied
1
Description of health condition studied
Painless after administraion of morphin
ICD-10 code
T40.2
ICD-10 code description
Other opioids Morphine
Primary outcomes
1
Description
Appointment amount of painless with interatecal of morphin
Timepoint
After Spinal Anesthesia any one hour for 12 hour
Method of measurement
Method of Visual analog scale
Secondary outcomes
1
Description
Measure outcome amount of nausia and vomitting in tow Group
Timepoint
After spinal anesthesia every one Hour for 12 hours
Method of measurement
Check list and existing vomiting and nausia
2
Description
Amount of itching
Timepoint
After spinal anesthesia every one Hour for 12 hours
Method of measurement
Check list and existing itching or not
3
Description
Measuring changing heart rate and blood pressure
Timepoint
After spinal anesthesia every one Hour for 12 hours
Method of measurement
Check list
Intervention groups
1
Description
In this group pationt under spinal anesthesia with 3 cc Marcain 0.5 precentage and 0.2 miligram morphin interathecal and amount of painless and amount of itching and nausia and vomitting and changing heart rate and boold pressure every one houre for 12 houre mesuring
Category
Treatment - Drugs
2
Description
In the control group pationt under spinal anesthesia with 3 CC Marcain 0.5 precentage and 1 cc free water interathecal and amount of painless and amount of itching and nausia and vomitting and changing heart rate and boold pressure every one houre for 12 houre mesuring
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital, Qazvin
Full name of responsible person
Abolghasem Ahmadvand
Street address
Rajee Hospital ; Padegan Avenu ; Qzvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Mahnaz Abbasi
Street address
Qazvin University of Medical Sciences; Navab Avenue
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Abolghasem Ahmadvand
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences; Navab Avenue
City
Qazvin
Postal code
Phone
+98 28 1333 5800
Fax
Email
aahmadvand@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abolghasem Ahmadvandvand
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences; Navab Avenue
City
Qazvin
Postal code
Phone
+98 28 1333 5800
Fax
Email
aahmadvand@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abolghasem Ahmadvand
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Qazvin University Of Medical Sciences; Navab Avenue
City
Qazvin
Postal code
Phone
Fax
Email
aahmadvand@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)