Determine effect of intravenous lidocaine on postoperative pain severity and immune response in mastectomy surgery.
Design
This is a double blinded randomized clinical trial that will be done on 50 patients who will candidate for elective mastectomy.Patients will be randomly allocated into two groups those who received intravenous lidocaine ( n=25) and control group (n=25).Anesthesiologist, patients, all of the collaborating personnel will be blinded to study's group of patients.20 min before general anesthesia, patients received 2mg/Kg bolus dose of lidocaine then intravenous infusion(1.5 mg/Kg) of lidocaine with infusion pump will be started till end of operation. Postoperative Pain severity according to VAS will be recorded and will be compared.Also, serum level of interleukin and 6 in the morning of operation and 24 hr post operation between both groups will be measured and compared.
Settings and conduct
This is a randomized, double blinded clinical trial , single center.For blindness, all of the drugs solution( lidocaine and normal saline) of this study will be prepared in 50 ml syringes that are equal in shape by only person who aware of study's groups .Anesthesiologist, patients all collaborate study's persons will not aware of patients group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients who will be candidate for elective mastectomy due to breast tumor
Exclusion criteria:Emergency patient;History of cardiac arrhythmia;Diabetes mellitus; Immune suppressive drugs; Corticosteriods;NSAIDs,; Renal and Liver failure; Hypersensetivity to lidocaine or contraindication of use of lidocaine.
Intervention groups
Intervention group: 20 min before general anesthesia, patients received 2mg/Kg bolus dose of lidocaine then intravenous infusion(1.5 mg/Kg) of lidocaine with infusion pump will be started till end of operation.
Main outcome variables
Postoperative Pain severity according to VAS will be recorded and will be compared.Also, serum level of interleukin and 6 in the morning of operation and 24 hr post operation between both groups will be measured and compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121204011662N11
Registration date:2018-01-09, 1396/10/19
Registration timing:registered_while_recruiting
Last update:2018-01-09, 1396/10/19
Update count:0
Registration date
2018-01-09, 1396/10/19
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of perioperative intravenous lidocaine in modified radical mastectomy on postoperative pain and immune function
Public title
Survey of the effect of the intravenous lidocaine during mastectomy on post operative pain and immune response.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who will be candidate for elective mastectomy due to breast tumor
Exclusion criteria:
Emergency patient;History of cardiac arrhythmia;Diabetes mellitus; Immune suppressive drugs; Corticosteriods;NSAIDs,; Renal and Liver failure; Hypersensetivity to lidocaine or contraindication of use of lidocaine.
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, All of the drugs solution( lidocaine and normal saline) of this study will be prepared in 50 ml syringes that are equal in shape by only person who aware of study's groups .Anesthesiologist, patients all collaborate study's persons will not aware of patients group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz Medical School Research Ethic Committee
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.SUMS.MED.REC.1396.87
Health conditions studied
1
Description of health condition studied
Postoperative pain and Immune response
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Severity of postoperative pain
Timepoint
Every 15 min in the recovery room, then 4, 8, 12,24 hr post operation in ward.
Method of measurement
Visual analog Scale
2
Description
immune system response
Timepoint
In the morning of operation and 24 hr post operation.
Intervention group: 20 min before general anesthesia, patients received 2mg/Kg bolus dose of lidocaine then intravenous infusion(1.5 mg/Kg) of lidocaine with infusion pump will be started till end of operation.
Category
Treatment - Drugs
2
Description
Control group: In this group 20 minutes before general anesthesia, patients received 2ml /Kg bolus dose of the physiologic saline then intravenous infusion(1.5 ml/Kg/hr) of the physiologic saline with infusion pump will be started till end of operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Training and Medical Center
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Zand Blv
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Fax
+98 71 3233 1634
Email
faghihihsp@sums.ac.ir
Web page address
http://faghihi.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences building, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Grant No:14165
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available