The purpose of this study is evaluating of analgesic effect of preemptive lidocain infusion on postoperative pain and opioid consumption after tibial fracture surgery. 48 patients participated in this randomized double-blinded study . patients were grouped as lidocain and control group. 24 Patients received lidocaine (lidocaine group) with a 1.5 mg/kg intravenous bolus and followed by a 1.5 mg / kg / hrs intravenous infusion And 24 patients received saline( control group). Visual analog scale (VAS) scores at 1 -2-4-12 -16 -20-24, the time to first analgesic requirement ,total analgesic consumption in first 24hrs and side effect were noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104306337N1
Registration date:2011-09-22, 1390/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Vahid Salehi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8307
Email address
salehi.v@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2010-10-12, 1389/07/20
Expected recruitment end date
2011-06-11, 1390/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of prioperative intravenous lidocaine infusion on post operative pain and analgesic requirement in tibial fracture surgery
Public title
Evaluation of the effect of prioperative intravenous lidocaine infusion on post operative pain and analgesic requirement in tibial fracture surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patients undergoing tibial fracture surgery under general anesthesia; age 18-50inclusive; ASA class I patients ; Body Mass Index (BMI) of 18.5-35 (Includes 18.5 to 25 – healthy range; >25-30 overweight; >30-35 Obese Class I);
Exclusion Criteria: patients under age 18 or over age50; ASA,II III, IV and V class patients ; Obese Class II patients (BMI>35) or undernourished (BMI<18.5); history of Liver dysfunction ; renal insufficiency; history of seizure disorder; hypersensitivity or allergy to amide type local anesthetics; medication use(daily use of any opiods or analgesic) and any chronic pain syndromes ;
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Ahvaz Jondishapour university of medical sciences
Street address
Shaher daneshgah
City
Ahvaz
Postal code
6135715794
Approval date
2010-10-09, 1389/07/17
Ethics committee reference number
ETH009
Health conditions studied
1
Description of health condition studied
Pain relief after tibial fracture surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pethedine consumpsion
Timepoint
1, 2, 4, 12 , 16 , 20 and 24 hours post extubation
Method of measurement
Medical records
Secondary outcomes
1
Description
Pain
Timepoint
1, 2, 4, 12 , 16 , 20 and 24 hours after extubation
Method of measurement
Visual analog scale (VAS)
Intervention groups
1
Description
Patient s in control group received normal saline IV infusion
Category
Placebo
2
Description
Patients in intervention group received lidocaine (lidocaine group) with a 1.5 mg/kg intravenous bolus and followed by a 1.5 mg . kg intravenous infusion
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospitaL
Full name of responsible person
Dr. Sholeh Nesioonpour
Street address
Azadegan St.
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
129006
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Sholeh Nesioonpour
Position
Assistant professor
Other areas of specialty/work
Street address
General operation room, Imam Khomeini hospital
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 5763
Email
Dr.nesioun@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Pipelzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Imam khomini Hospital, Azadegan St.
City
AHVAZ
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1222 2114
Email
dr_rpipel@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vahid Salehi
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Imam khomini hospital, Azadegan St
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1338 0138
Fax
Email
salehivahid61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)