The aim of this study is to investigate the effect of laser on acute post operative pain after leg surgery in patients undergoing spinal anesthesia. In this prospective double blind randomized study 54 patients were divided in intervention and control group. Inclusion criteria : ASA class I & II ; 18-50 years old . Exclusion criteria:pregnancy,malignancy,benign tumors with probability of being malignant,hyperensitivity to light like lupus and contraindications of spinal anesthesia(patient refusal,infection at the site of planned needle puncture,elevated intracranial pressure and bleeding diathesis).
Spinal anesthesia with 12.5 mg Marcaine will done in both groups equally. in intervention group 27 patients received red and infra red laser radiation at the end of surgery. and in control group 27patients received off laser after surgery. Postoperative pain and needs for analgesics will measured at 2 , 4 , 8 , 12 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121410509N4
Registration date:2013-03-09, 1391/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Sholeh Nesioonpour
Name of organization / entity
Ahvaz Jundishapur Medical University
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
nesioonpour-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of low level laser on reducing the post operative acute pain in patients who have been undergoing leg surgery
Public title
The effect of low level laser on pain after leg surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :
ASA class I & II ; 18-50 years old .
Exclusion criteria :
pregnancy ; malignancy ; benign tumors with probability of being malignant ; hyperensitivity to light like lupus ; contraindications of spinal anesthesia(patient refusal ; infection at the site of planned needle puncture ; elevated intracranial pressure and bleeding diathesis)
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:
54
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 Jundishapur University of Medical Science
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
ETH-654
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
acute pain
Primary outcomes
1
Description
Pain
Timepoint
2,4,8,12,24 hour after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
24 hours after surgery
Method of measurement
milligram
Intervention groups
1
Description
In intervention group patients received infrared and red laser radiation after the end of surgery
Category
Prevention
2
Description
In control group patients received off laser after the end of surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Salman Vojdani
Street address
Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr Mostafa Feghhi
Street address
Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr Salman Vejdani
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Azadegan Avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
salman6365@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
nesioonpour-sh@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan Ave , Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
nesioonpour-sh@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)