Clinical trial of evaluation of the efficacy of low level laser in comparison with off laser on postoperative pain in patients who have been undergoing cesarean section
The aim of this study is to investigate the effect of low level laser on acute post operative pain after cesarean section in patients undergoing spinal anesthesia. In this prospective double blind randomized study 70 patients were divided randomly in intervention and control groups . Inclusion criteria:gravid1,2 ; 18-40 years old ; ASAI,II. Exclusion criteria : patient refusal ; elevated intracranial pressure ; bleeding diathesis ; infection at the site of planned needle puncture ; lower extremity peripheral neuropathy ; classic cesarean scar ; malignancy ; benign tumors with probability of being malignant ; hypersensitivity to light like lupus ; history of convulsion ; spinal anesthesia with 12 milligram bupivacaine will done in both groups . In intervention group35 patients received Red and Infrared laser after surgery. In control group patients received off laser . Postoperative pain and pethidine consumption will measured at 1,4,8,12,16 and 24 hours after surgery. the operator of laser know the patient group and the patients and the person who complete questionnaire are blinded to patient groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061210509N5
Registration date:2015-03-17, 1393/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-17, 1393/12/26
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
2013-05-11, 1392/02/21
Expected recruitment end date
2014-07-12, 1393/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation of the efficacy of low level laser in comparison with off laser on postoperative pain in patients who have been undergoing cesarean section
Public title
The effect of low level laser on postoperative pain after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Pregnant women 18-40 years ; gravid 1,2 ; ASA Class I,II
Exclusion Criteria : patient refusal ; elevated intracranial pressure ; bleeding diathesis ; infection at the site of planned needle puncture ; lower extremity peripheral neuropathy ; classic cesarean scar ; malignancy ; benign tumors with probability of being malignant ; hypersensitivity to light like lupus ; history of convulsion
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
the operator of laser know the patient group and the patients and the person who complete the questionnaire are blinded to patient groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Science
Street address
Golestan, Shahrak Daneshgah
City
Ahvaz
Postal code
Approval date
2013-05-11, 1392/02/21
Ethics committee reference number
ajums.rec.1392.40
Health conditions studied
1
Description of health condition studied
Postoperative Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain
Timepoint
1,4,8,12,16,24 hours after end of anesthesia
Method of measurement
VAS questionnaire
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
24 hours after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
In intervention group patients received infrared and red laser(PLP-IR-808nm-200mw, PLP-R-650nm-100mw) radiation manufactured by COL center-Canada once after the end of surgery
Category
Prevention
2
Description
In control group patients received off laser once 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 Sholeh Nesioonpour
Street address
Azadegan Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Dr Nader Saki
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, Vice Chancellor for Research and Technology
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 University of Medical Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Shahrak Daneshgah , Golestan
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 Sciences
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 611220168
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 Sciences
Full name of responsible person
Dr Sholeh Nesioonpour
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Shahrak Daneshgah , Golestan
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)