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Comparison of intrathechal morphine analgesic effect after post operative lumbar vertebral fusion surgery in addict and non-addict patients admitted in Ahwaz Golestan hospital’s neurosurgery ward.

Protocol summary

Summary
Objectives: Measurement of analgesic effect of intrathecal morphine in lumbar spine surgery and compare of their side effects with systemic morphine administration Design: In admission the patients randomly will be divided to 4 groups (addict case &control and non addict case & control). Patients in case groups (addict, non addict) will be injected with 0.3 mg intrathecal morphine before terminating of spinal fusion surgery. Patients of control group will not receive any medication. Pain of patients measured with visual analogue score (with 10 CM no -calibrated ruler) in 0(before anesthesia), 4, 8,12,18,24 hours after surgery. In ward if the pain of patients exceeds 50/100 will injected 1 mg IV slowly morphine When the end of surgery to the first intravenous injection of morphine for each patient will be measured and recorded. And all side effects (nausea, vomiting, pruritus, headache, urinary retention and respirator suppression) will be recorded throughout the study period. Then data will be analyzed with SPSS. For data analyzes descriptive statics (mean, standard deviation), charts will be used, and also paired T-test will be used to compare the pain level of patients in two state. Independent T-test and chi-square will be used for comparison. P≤0/05 will be statistically significant. Main outcome measures variables: Post operative pain score and mean intravenous morphine use. inclusion criteria: All patients with lumbar vertebral fracture that candidate to surgery. exclusion criteria: patients with life threatening multiple trauma (eg: sever chest or abdominal); patients with severe medical disorder (eg: cardiopulmonary, renal failure, hepatic failure); patients with history of morphine or opiate allergy; pregnant patients; patients under 15 years old; patients with addiction to other substance such as: crack, ecstasy, cannabinoid, marijuana, other illicit drugs; patients with pre or post operative neurologic deficit

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012065325N1
Registration date: 2011-09-03, 1390/06/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-03, 1390/06/12
Registrant information
Name
Reza Bahrami Ilkhchi
Name of organization / entity
Ahwaz Jondishapour University
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3032
Email address
bahrami.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahwaz Jondishapour University
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrathechal morphine analgesic effect after post operative lumbar vertebral fusion surgery in addict and non-addict patients admitted in Ahwaz Golestan hospital’s neurosurgery ward.
Public title
Pain in spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with lumbar vertebral fracture that candidate to surgery. exclusion criteria: patients with life threatening multiple trauma (eg: sever chest or abdominal); patients with severe medical disorder(eg: cardiopulmonary, renal failure ,hepatic failure); patients with history of morphine or opiate allergy; pregnant patients; patients under 15 years old; patients with addiction to other substance such as: crack, ecstasy, cannabinoid, marijuana, other illicit drugs; patients with pre or post operative neurologic deficit.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Ethic committee of Jondishapour Medical University
Street address
Vice chancellor for research, Jondishapour University, Golestan st
City
Ahwaz
Postal code
Approval date
2010-12-31, 1389/10/10
Ethics committee reference number
eth020

Health conditions studied

1

Description of health condition studied
Lumbar spine fracture
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra

Primary outcomes

1

Description
Rate of Morphine used
Timepoint
0.4.8.12.18.24 hour post operation
Method of measurement
In data collection form

Secondary outcomes

1

Description
Patient pain
Timepoint
0.4.8.12.18.24 hour post operatin
Method of measurement
Visual analog score

Intervention groups

1

Description
Addict case group:0.3 mg intratechal morphine injection for preemptive analgesia
Category
Treatment - Drugs

2

Description
Addict control group:no intervention Non addict control groups:no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital neurosurgery ward
Full name of responsible person
Dr.Reza Bahrami Ilkhchi
Street address
Ahwaz Jondishapour University of Medical Science
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Dr.Masud Zeinali
Street address
Ahwaz Jondishapour Medical University
City
AhWaz
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 of Ahwaz Jondishapour 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
Ahwaz JondiShapour Medical University
Full name of responsible person
Dr.Reza Bahrami Ilkhchi
Position
Neurosurgery resident
Other areas of specialty/work
Street address
Neurosurgery ward, Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3032
Fax
+98 61 1374 3032
Email
bahrami.r@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jondishapour Medical University
Full name of responsible person
Dr.Masud Zeinali
Position
Neurosurgery proffesor assisted
Other areas of specialty/work
Street address
Nerusurgery ward, Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3032
Fax
+98 61 1374 3032
Email
bahrami.r@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz JondiShapour university, Medicine faculty
Full name of responsible person
Dr.Reza Bahrami Ilkhchi
Position
Neurosurgery resident
Other areas of specialty/work
Street address
Neurosurgery ward, Golestan hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3032
Fax
+98 61 1374 3032
Email
bahrami.r@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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