Protocol summary

Summary
Present study was designed for assessment impact of intravenous methylprednisolone on postoperative pain in Intertrochanteric fracture. 40-70 years patients with Intertrochanteric fracture were included and randomly allocated into the trial and control groups. Thirty minutes before operation, patients received one dosage of methylprednisolone (2 cc, 125 mg) in trial group and 2 cc normal saline (isotonic saline) in control group. Postoperative pain in patients was assessed by VAS at 4, 6, 12, 36 and 48 hours after operation. Nausea and vomiting and CRP level were measured and compared with control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051113182N1
Registration date: 2013-09-21, 1392/06/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-21, 1392/06/30
Registrant information
Name
Amir Bahrami-Ahmadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 496 9707
Email address
bahramia@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2014-10-02, 1393/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intravenous methylprednisolon on postoperative pain in patients with intertrochanteric femur fracture
Public title
Effect of methylprednisolon on postoperative pain in femur Fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age between 40-70; having writing and verbal ability; Exclusion criteria:S-A contraindication; Failure in previous S-A; having renal failure;having peptic ulcer; having diabetes I or II; Neuropathy in RA patients that have steroid or immunosupressive usage in previous 6 months; Marcaine, Methyl prednisolon, fenatanile sensitivity;Alcoholism;smoking/addiction;pregnant women
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
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
Tehran Univerisyt of Medical Sciences
Street address
TUMS Buliding- Ghods cross road, Keshavarz Blv- Tehran,Iran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
901302138

Health conditions studied

1

Description of health condition studied
One sided intertrochanteric femur fracture
ICD-10 code
S 72-8
ICD-10 code description
Fractures of other parts of femur

Primary outcomes

1

Description
postoperative pain
Timepoint
at 4,6,12,24,36,48 hours after operation
Method of measurement
VAS

Secondary outcomes

1

Description
post operative neaseua and vomiting
Timepoint
post operative time
Method of measurement
via patients observation

Intervention groups

1

Description
Intervention in Trial group: intravenous 2 cc equal with 125 milligrams methylprednisolon (one dosage)
Category
Treatment - Drugs

2

Description
Intervention in Control group: 2 cc normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrateh Rasul Akram Hospital
Full name of responsible person
Hamid Reza Faiz M.D
Street address
Hazrateh Rasul Akram Hospital- Niayesh Street, Satarkhan- Tehran,Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Bahrami-Ahmadi
Street address
Thran University of Medical Sceinces, Qhods cross road, Keshavarz Blv,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of medical sciences
Full name of responsible person
Dr Hamid Reza Faiz
Position
Assistant professor of Anesthesiology group
Other areas of specialty/work
Street address
Hazrate Rasoul akram hospital- Niayesh street, Satarkhan street-Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
hrfaiz@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Hamid Reza Faiz
Position
Assistant professor of anesthesiology group
Other areas of specialty/work
Street address
Hazrateh Rasul Akram Hospital- Niaiesh street, Satarkhan street-Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
hrfaiz@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Bahrami-Ahmadi
Position
Researcher
Other areas of specialty/work
Street address
Hazrateh Rasul Akram Hospital- Niayesh Street, Satarkhan- Tehran,Iran
City
Tehran
Postal code
Phone
+98 912 496 9707
Fax
Email
a-bahrami@farabi.tums.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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