The effect of infusion of intravenous Acetaminophen at the end of surgery on post operative recovery room pain and discharge time in Lumbar Discectomies.
In a randomized doble blinded controlled trial,52 patients scheduled for lumbar discectomy were randomly allcated into two groups recieved intravenous paracetamol within the last 20 minutes of the surgery as the case group or normal saline as the control group.after that different variants such as VGS.PS.blood pressure.heart rate.nausea. vomiting and recovery discharge time will be recorded. If the infusion of intravenous acetaminophen decrease the pain after lumbar discectomies we can use it inspite of opioids.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102912853N4
Registration date:2014-03-03, 1392/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Mohammad Shimia
Name of organization / entity
Tabriz University of Medical Sciences and Health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7774
Email address
shimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student Research Committee of Tabriz University of Medical Science
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infusion of intravenous Acetaminophen at the end of surgery on post operative recovery room pain and discharge time in Lumbar Discectomies.
Public title
The effect of infusion of intravenous acetaminophen on pain in lumbar discectomies.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients that have disc involvment at the same levels and do not have exclusion criterias.
Exclusion criteria:patients that have drug addiction.liver disease.cardiopulmonary disease.psychological disease.sever obesity.age under 20 years and upper 65 years.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
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
Tabriz University of Medical Science Ethics Committee
Street address
Tabriz . Daneshgah st . Tabriz University of Medical Science.
City
Tabriz
Postal code
Approval date
2013-07-07, 1392/04/16
Ethics committee reference number
5/4/3196
Health conditions studied
1
Description of health condition studied
pain in lumbar discetomy
ICD-10 code
M51
ICD-10 code description
Other intervertebral disc disorders
Primary outcomes
1
Description
pain
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
Visual ghraphycal scale
Secondary outcomes
1
Description
swelling
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
inspection
2
Description
heart rate
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
by cardiac monitoring
3
Description
blood pressure
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
mmHg. blood pressure monitor
4
Description
nausea
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
asking
5
Description
vomiting
Timepoint
minute:5.10.15.20.25.30.35.40.discharge time
Method of measurement
inspection
6
Description
Recovery Discharge Time
Timepoint
time to discharge to ward
Method of measurement
time recording
Intervention groups
1
Description
in case group:15 mg/kg intravenous acetaminophen in 100 cc salin normal/iv. within 20 min at the end of surgery.
Category
Treatment - Drugs
2
Description
in control group:100cc serum salin normal/iv/within 20 min at the end of surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Shohada Hospital
Full name of responsible person
Dr Mohammad Shimia
Street address
Tabriz.Shahgoli Street.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Comitte Of Tabriz University Of Medical science
Full name of responsible person
Hanieh Azizi
Street address
Tabriz, Daneshgah Street, in front of Shahid Madani Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Comitte Of Tabriz University Of Medical science
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
Tabriz University Of Medical Science
Full name of responsible person
Mahdokht Ghanbari
Position
Medical Student(Intern)
Other areas of specialty/work
Street address
Tabriz, Daneshgah Street, Tabriz University Of Medical Science
City
Tabriz
Postal code
Phone
+98 41 1334 4802
Fax
Email
drsorkhabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Dr Mohammad Shimia
Position
Daneshyar
Other areas of specialty/work
Street address
Tabriz, Daneshgah Street, Tabriz University Of Medical Science
City
Tabriz
Postal code
Phone
+98 41 1334 4802
Fax
Email
shimia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Mahdokht Ghanbari
Position
Medical Student(Intern)
Other areas of specialty/work
Street address
Tabriz, Daneshgah Street, Tabriz University Of Medical Science
City
Tabriz
Postal code
Phone
+98 41 1334 4802
Fax
Email
drsorkhabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)