All patient who accept to participate in the study divided to two equals group randomly(n=30). In case group all patient recieve facia illica block with 20 CC bupivacainene 0.5%( 100 mg.fascia iliaca block is an injection under the inguinal region (femoral or fascia iliaca block); while doing, fascia iliaca block anaesthetic solution is distributed to the femoral nerve, lateral femoral cutaneous nerve and occasionally to the genito-femoral nerve and this made patient painless for a long time. In control group all patient recieve 600 mg of gabapentin 2 hours before surgery. Post operative pain score,first demand of analgesic and total amount of analgesic in first 24 hours will be noted and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203021936N9
Registration date:2012-06-07, 1391/03/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-07, 1391/03/18
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2012-07-01, 1391/04/11
Expected recruitment end date
2012-11-01, 1391/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between the effect of preemptive Gabapentin and Fascia Iliaca block in reduction of postoperative pain of femoral shaft surgery
Public title
The Comparison between the effect of preemptive Gabapentin and Fascia Iliaca block in reduction of postoperative pain of femoral shaft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: all patients with femoral shaft fracture between 18 till 45 years old who sign consent form. Exclusin criteria: sensitivity to gabapentin; local anesthetic; history of opioid abuser; peripheral neuropathy; asthma; diabetes mellitus and use of analgesic 8 hours before surgery.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr university of medical college
Street address
Bushehr -siraf avenue
City
Bushehr
Postal code
Approval date
2012-05-06, 1391/02/17
Ethics committee reference number
B-91-14-1
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post operative pain
Timepoint
24 hours
Method of measurement
Visual pain score
Secondary outcomes
1
Description
First demand for analgesic
Timepoint
First 24 hours
Method of measurement
Patients medical records
Intervention groups
1
Description
In control group all the patients recieve 600 mg Gabapentin orally 2 hours before surgery. Gabapentin is a gaba amino buteric acid inhibitor and can prevent post operative pain
Category
Treatment - Drugs
2
Description
In experimental group all the patient recieve facia illica block just before surgey with 20 mililiter bupivacaine .05% fascia iliaca block is an injection under the inguinal region (femoral or fascia iliaca block), When you do fascia iliaca block anaesthetic solution is distributed to the femoral nerve, lateral femoral cutaneous nerve and occasionally to the genito-femoral nerve and this made patient painless for a long time
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahar hospital
Full name of responsible person
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Majid Asady
Street address
Bushehr university of medical science-dr najafianaraki
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr- Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Abdolreza Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Bushehr
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Abdolreza Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr-Bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1252 2417
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)