This study is a double-blind randomized clinical trial (RCT). The aim of this study is to evaluate the Effect of intravenous Lidocaine on pain intensity after Cesarean section. 100 patients, who qualified for study entry, randomly allocate in two equal intervention and control groups. Inclusion criteria are: willingness to enter the study and informed written consent; ASA class 1&2; Elective cesarean surgery; Age between 20 and 35 years. Exclusion criteria are: Unwillingness to continue the study; Known lidocaine sensitivity; surgery time more than 1/5 hours; Midline incision for any reason; Any unusual complication during surgery. Intervention group receive Lidocaine IV 1/5 mg/Kg and control group receive Normal saline during induction of anesthesia. During 24 hours after surgery pain intensity (VAS), prescribed diclofenac suppository (100 mg if VAS>3) and IV morphine (3 mg if VAS>5), Nausea and vomiting, Patient satisfaction of pain control are measured in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408114365N17
Registration date:2014-08-20, 1393/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-20, 1393/05/29
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous Lidocaine on pain intensity after Cesarean section
Public title
Effect of intravenous Lidocaine on pain intensity after Cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to enter the study and informed written consent; ASA class 1&2; Elective cesarean surgery; Age between 20 and 35 years.
Exclusion criteria: Unwillingness to continue the study; Known lidocaine sensitivity; surgery time more than 1/5 hours; Midline incision for any reason; Any unusual complication during surgery.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethic committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
46175866
Approval date
2013-02-02, 1391/11/14
Ethics committee reference number
91-212
Health conditions studied
1
Description of health condition studied
pain intensity after Cesarean section
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Pain intensity
Timepoint
2, 4, 6, 12, 24 hour after surgery
Method of measurement
VAS) Visual Analog Scale
Secondary outcomes
1
Description
Patient satisfaction of pain control
Timepoint
During 24 hours after surgery
Method of measurement
Data collecting form
2
Description
Nausea and vomiting
Timepoint
During 24 hours after surgery
Method of measurement
Data collecting form
3
Description
Used morphine amount
Timepoint
During 24 hours after surgery
Method of measurement
Data collecting form
4
Description
Used diclofenac amount
Timepoint
During 24 hours after surgery
Method of measurement
Data collecting form
Intervention groups
1
Description
Intervention group: Lidocaine IV 1/5 mg/Kg is infused during induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Normal saline is infused during induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
afshin gholipour baradari, MD, CCMF, associate professor
Street address
Imam Khomeini general Hospital, Amir St.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati, MD
Street address
Mazandaran university of medical sciences, Moallem Square- Sari- Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Associate Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 11 3326 2679
Fax
Email
gholipourafshin@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari, MD
Position
CCMF, Associate Professor, Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 11 3326 2679
Fax
Email
; gholipourafshin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian, MD
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Khomeini General Hospital, Amir St
City
Sari
Postal code
48175-866
Phone
+98 11 3326 2679
Fax
+98 15 1326 2679
Email
ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)