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comparison of the effect of low level laser and lidocaine with lidocaine alone on tourniquet pain during surgery of distal radius fracture with intravenous regional block

Protocol summary

Summary
The aim of this study is evaluation of the effect of low level laser on reducing tourniquet pain during surgery of distal radius fracture with intravenous regionl block. In this prospective double blind randomized study 48 patient were divided in intervention and control group . Inclusion criteria : ASA class I & II ; 18-50 years old . Exclusion criteria : raynaud disease ; scleroderma ; sickle cell anemia ; malignancy ; photo sensitivity ; convulsion ; pregnancy . Intravenous regional block with lidocaine is done in both groups equally. , in intervention group 24 patient received infra red laser radiation after tourniquet inflation and in control group 24 patient received off laser after tourniquet inflation .Tourniquet pain was measured at 10 , 20 , 30 , 40 and 50 minutes after tourniquet inflation by Visual Analogue Scale . Postoperative pain was measured at 2 , 4 , 8 , 12 and 24 hour after tourniquet deflation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012081810509N3
Registration date: 2012-12-14, 1391/09/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-14, 1391/09/24
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 Sciences
Expected recruitment start date
2012-04-24, 1391/02/05
Expected recruitment end date
2012-11-25, 1391/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of low level laser and lidocaine with lidocaine alone on tourniquet pain during surgery of distal radius fracture with intravenous regional block
Public title
Effect of low level laser on torniquet pain in intravenous regional block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : ASA class I & II ; 18-50 years old Exclusion criteria : raynaud disease ; scleroderma ; sickle cell anemia ; malignancy ; photo sensitivity ; convulsion ; pregnancy
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 Jundishapur University of Medical science
Street address
Shahrak Daneshgah , Golestan
City
Ahvaz
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
ETH-441

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
10 , 20 , 30 , 40 , 50 minute after tourniquet inflation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Postoperative Pain
Timepoint
2 , 4 , 8 , 12 , 24 hour after surgery
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
In control group patients received off laser after tourniquet inflation
Category
Prevention

2

Description
In intervention group patients received infra red laser radiation after tourniquet inflation
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 Avenue
City
Ahvaz

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
Shahrak Daneshgah , 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 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
School of Medicine , Ahvaz Jundishapur of Medical Science
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Azadegan Avenue , 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 scientific inquiries

Contact
Name of organization / entity
School of Medicine , 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
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
School of Medicine , 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
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)
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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