Objective: Evaluating the analgesic efficacy of intravenous lidocaine in patients undergoing cesarean section under spinal anesthesia. Design: this study will be a randomized, double-blinded, placebo-controlled clinical trial in Kowsar teaching hospital in Qazvin. Setting and conduct: Following Ethics Committee approval and informed patients consent, eighty parturient patients ASA physical status I or II, scheduled for cesarean section under spinal anesthesia will be randomly allocated to one of two groups of 40 each. The lidocaine group (group L) will receive, 1.5 mg/kg of bolus Lidocaine 2% intravenously 15 minutes before spinal anesthesia and infusion of Lidocaine 2%(1.5 mg/kg/h) for one hour after beginning of surgery. .The control group will receive bolus dose of Normal Saline intravenously instead of Lidocaine (in same volume of Lidocaine based on milliliter) 15 min before spinal and maintenance dose of Normal Saline will continue one hour from beginning of surgery. Time to first analgesic requirement after surgery, duration of sensory and motor blockade, hemodynamics variables and Adverse events such as hypoxia (oxygen (SpO2)<90], bradycardia, hypotension, nausea and vomiting will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610023051N11
Registration date:2016-12-09, 1395/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous lidocaine on postoperative analgesia in cesarean section under spinal anesthesia
Public title
Evaluation of analgesic efficacy of lidocaine infusion in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Elective cesarean surgery; patients aged 18 to 45 years, ASA class 1 and 2.
Exclusion criteria: complete heart block; Severe bleeding and coagulation disorder; Severe hypotension and shock; septicemia; history of CNS disease; hyperthyroidism; hypertension; history of hepatorenal disease; Cardiovascular disease; diabetes; Allergy to lidocaine; placenta praevia; Placental abruption; cesarean induced deceleration Fetal heart rate (FHR); meconium; addict; contradiction of regional analgesia; eclampsia and preeclampsia; user of Beta blocker and glycoside.
Age
From 18 years old to 45 years old
Gender
Female
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
Random sampling is based on selection of colorful cards
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.QUMS.REC.1394.216
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Time to first analgesic requirement
Timepoint
During 24 hrs after the surgery
Method of measurement
Hour
2
Description
Sensory block level and recovery of sensory block to T10
Timepoint
30 and 60 seconds after injection
Method of measurement
Pin prick method
3
Description
Motor block level and recovery of motor block
Timepoint
30 and 60 seconds after injection
Method of measurement
Bromage scale
4
Description
Hemodynamic changes (bradycardia, hypotension and Oxygen saturation <90] )
Timepoint
From the time of intervention; every 5 minute until 15 minute then every 15 minute until 1 hour
Method of measurement
Monitoring devise
Secondary outcomes
1
Description
Secondary effects
Timepoint
During 6 hrs after the surgery
Method of measurement
According patient's history
2
Description
Neonate APGAR
Timepoint
In the first and fifth minute from birth
Method of measurement
APGAR criteria
Intervention groups
1
Description
In control group, we injected bolus dose of Normal Saline intravenously instead of Lidocaine.(in same volume of Lidocaine based on milliliter) 15 min before spinal anesthesia. then maintenance dose of Normal saline continue one Hour from beginning of surgery
Category
Placebo
2
Description
In treatment group, 15 minutes before spinal anesthesia, 1.5 mg/kg of bolus Lidocaine 2% injected intravenously then, we infuse maintenance dose of IV Lidocaine 2%(1.5mg/kg/h) and Infusion of drug should be continue one Hour from beginning of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Koosar hospital
Full name of responsible person
Dr. Maryam Rajabi
Street address
Valiasr street, Qazvin.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Maryam Rajabi
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Koosar hospital, Valiasr street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 6380
Fax
Email
dr.108162@gmail.comvcrc92@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr.Marzieh Beigom Khezri
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Koosar hospital, Valiasr street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 6380
Fax
Email
mkhezri88@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Marzieh Beigom Khezri
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Koosar hospital, Valiasr street, Qazvin
City
Qazvin
Postal code
Phone
00
Fax
Email
mkhezri88@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)