Protocol summary

Summary
Aim of Study: Postoperative pain is among the problems which lack of control on it has many side effects. In this study we evaluated the preoperative administration of pregabalin sufficiency and security in relieving postoperative pain after lower limb orthopedic surgery and reducing the need for opioids and their possible side effects. Critical inclusion criteria: The patients candidate for lower limb surgery in pelvic, femur and leg under general anesthesia Critical exclusion criteria: Patients with pregnancy, neurological disease, psychiatric disorders, acute or chronic renal disease, history of peptic ulcer, history of allergy to pregabalin Study population and sample size: This study is a randomized, double-blind clinical trial. It is performed on 60 patients under lower limb surgery in pelvic, femur and leg who refer to Ardabil Fatemi Hospital. Patients are randomly allocated to two groups, one group receive a 150 mg pregabalin capsule 2 hours before surgery and the other group receive placebo as a control. In both groups after surgery, the patients are evaluated and the pain score, the score of sedation, incidence of nausea and vomiting during 24 hour after surgery are recorded in the checklists.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212254093N5
Registration date: 2013-01-06, 1391/10/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-06, 1391/10/17
Registrant information
Name
Masood Entezariasl
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1225 1688
Email address
m.entezari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral pregabalin effects on postoperative pain control after orthopedic surgery on farcture of lower limbs in Fatemi hospital in 2011
Public title
The effects of oral pregabalin on postoperative pain of lower limb fracture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for lower limb surgery in pelvic, femur and leg under general anesthesia;ASA class I-II Exclusion criteria: Patients with pregnancy;neurological disease;psychiatric disorders; history of seizures; acute or chronic renal disease;history of peptic ulcer;history of allergy to pregabalin or pethidine; taking psychotropic drugs;alcohol or drugs abuse;daily intake of analgesics
Age
From 20 years old to 60 years old
Gender
Both
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
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Approval date
2010-10-12, 1389/07/20
Ethics committee reference number
882/1

Health conditions studied

1

Description of health condition studied
lower limb fracture
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified

Primary outcomes

1

Description
pain
Timepoint
2-6-12-24 hours after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
sedation
Timepoint
2-6-12-24 hours after surgery
Method of measurement
ramsay sedation scoring

Intervention groups

1

Description
a 150 mg pregabalin capsules 2 hours before surgery
Category
Prevention

2

Description
a placebo capsule 2 hours before surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemi Hospital
Full name of responsible person
Dr Masood Entezariasl
Street address
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Akbar Pirzadeh
Street address
School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Ardabil, Iran
City
Ardabil
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Masood Entezariasl
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Ardabi, Iran
City
Ardabi
Postal code
Phone
+98 45 1772 3010
Fax
Email
m.entezari@arums.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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