The aim of this study is to evaluate the Efficacy of laser therapy as an analgesic treatment for patients undergoing open cholecystectomy.In this study that will take about a year after proposal registration;80 Patients 20 to 70 years old (men and women) who have been admitted for elective open cholecystectomy are selected after informed consent.Patients were randomly divided into two equal groups and laser irradiation will be done 5 times for each patient.First dose will be performed immediately after surgery and Subsequent doses will be conducted every 12 hours until the third day after the operation during hospitalization. Same number of sessions will be done for Placebo group with [OFF] device.Pain assessment will be performed by visual analog scale each 12 hours until the third day and day5 & 7 after surgery by Phone call.Finally two groups will be compared after analyzing information.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021721121N1
Registration date:2015-03-13, 1393/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-13, 1393/12/22
Registrant information
Name
Reza Movassaghi Gargari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 8740
Email address
movassaghir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of low level laser therapy on the post open cholecystectomy wound pain
Public title
Efficacy of laser therapy on the cholecystectomy wound pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All of Patients 20 to 70 years (men and women);Patients who have been admitted for elective open cholecystectomy.
Exclusion criteria:Patients who did not consent to participate in the study;Patients who their wound is infected for any reason;Patients who have other medical problems in addition to cholecystectomy (ASA II-IV), or addicted to any drugs or have psychotic disorders;Patients who have undergone abdominal surgery especially in epigastric area for any reason;Patients who their wounds is sutured by a method other than Continious method.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Medical Ethics Commitee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Medicine Faculty, Medical Ethics Commitee
City
Tabriz
Postal code
5165665931
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
92179
Health conditions studied
1
Description of health condition studied
Patients who have been admitted for elective open cholecystectomy.
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
Pain degree by VAS
Timepoint
Pain assessment will be performed by VAS Each 12 hours until third day and day5 & 7 after surgery by phone call
Method of measurement
According to visual analog scale
Secondary outcomes
1
Description
Painkillers and Opioid drugs Usage
Timepoint
Daily
Method of measurement
Depending on the dose in milligrams
Intervention groups
1
Description
After the surgery,the first group (control) which is consisted of 40 patients, in addition to conventional therapy such as intravenous and oral painkillers treat with the laser[OFF] (Placebo).Treatment rounds will be done 5 times for each patient.First time will be performed immediately after surgery and Subsequent times will be conducted every 12 hours until the third day after the operation during hospitalization.
Category
Treatment - Other
2
Description
After the surgery,The second group (study) which is consisted of 40 patients, in addition to conventional therapy such as intravenous and oral painkillers treat with the laser[ON] also.Laser irradiation will be done 5 times for each patient.First dose will be performed immediately after surgery and Subsequent doses will be conducted every 12 hours until the third day after the operation during hospitalization.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Research and Training Hospital
Full name of responsible person
Dr.Reza Movassaghi Gargari
Street address
Tabriz University of Medical Sciences,Imam Reza Medical Research and Training Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Hasan Soleimanpour
Street address
Tabriz University of Medical Sciences,Medicine Faculty,Deputy of Research and Technology
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Reza Movassaghi Gargari
Position
Assistant Professor of Department of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences,Medicine Faculty,Department of Anesthesiology
City
Tabriz
Postal code
5165665931
Phone
+98 41 3336 8740
Fax
+98 41 3335 2073
Email
rz_movassaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Reza Movassaghi Gargari
Position
Assistant Professor of Department of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences,Medicine Faculty,Department of Anesthesiology
City
Tabriz
Postal code
5165665931
Phone
+98 41 3336 8740
Fax
+98 41 3335 2073
Email
rz_movassaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Reza Movassaghi Gargari
Position
Assistant Professor of Department of Anesthesiology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences,Medicine Faculty,Department of Anesthesiology
City
Tabriz
Postal code
5165665931
Phone
+98 41 3336 8740
Fax
+98 41 3335 2073
Email
rz_movassaghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)