The main goal of this study is determining the effectiveness of intraoperative infusion of lidocaine on postoperative pain in laparoscopic cholecystectomy. This is a randomized clinical trial on 70 patients which are divided in two groups randomly using chances box.
Inclusion criteria are patient willingness to participation, ASA (American Society of Anesthesiologists) classification of I or II and elective laparoscopy.
Exclusion criteria are history of sensitivity to local analgesics, long-lasting use of narcotics and steroids, pregnancy and history of cardiac or other chronic diseases.
The method of anesthesia in both groups is identical. In first group 1.5 mg/kg lidocaine is administrated 10 minutes before anesthesia and maintenance dose of 2mg/kg/hr is given by infusion pump until the end of operation. In second group we administer placebo but induction medication and maintenance of anesthesia is similar to the first group. Blood pressure and heart rate of all is measured before induction, after beginning of surgery, at the time of starting CO2 course, and every 15 minutes throughout the procedure till the end of recovery period.
The patients’ pain is measured before anesthesia and after the procedure in recovery room using Visual Analogue Scale (VAS). In order to preventing analgesics’ effects on VAS, 30 minutes before the end of surgery administration of fentanyl (an analgesic) is stopped up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082110900N2
Registration date:2013-09-22, 1392/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Hosein Sattari
Name of organization / entity
kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
sattari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Kerman University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of intraoperative infusion of lidocaine on postoperative pain in laparoscopic cholecystectomy.
Public title
Can lidocaine infusion during laparoscopic surgery reduce the pain?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are patient willingness to participation, ASA (American Society of Anesthesiologists) classification of I or II and elective laparoscopy.
Exclusion criteria are history of sensitivity to local analgesics, long-lasting use of narcotics and steroids, pregnancy and history of cardiac or other chronic diseases and high blood pressure, age less than18 or more than 85, BMI more than 40, HR less than 50 and PR interval more than 0.2 sec. or any kind of cardiac block.
Age
From 18 years old to 85 years old
Gender
Both
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
After approving by Ethic Committee of Kerman University of Medical Sciences, informed consent will be obtained from the patients. The method of sampling is simple randomization which amongst studied members of community who are referred to operation rooms of Afzalipoor Hospital of kerman, one sample will be selected from the listed groups in the chances box by the patient accidentally. The medication is prepared by study leader and the anesthesiologist and technician who are responsible for taking care of the patient are blind to the medication as well as the patient. The preparation of patients in both group are similar and all the patients must be NPO for 8 hours before operation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical sciences
Street address
Jomhoori boulevard
City
Kerman
Postal code
Approval date
2013-09-21, 1392/06/30
Ethics committee reference number
k/92/223
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
pain
Timepoint
before and after operation
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
blood pressure
Timepoint
every 5 minutes and every 15 minutes in PACU
Method of measurement
digital monitoring device
2
Description
Heart Rate
Timepoint
every 5 minutes and every 15 minutes in PACU
Method of measurement
digital monitoring device
Intervention groups
1
Description
In intervention group Lidocaine (each ampoule contains 20 mg/ml Lidocaine, made by Daroopakhsh Co - Iran) with primary dose of 0.5 mg/kg and maintenance dose of 2 mg/kg/h is administered.
Category
Treatment - Drugs
2
Description
In control group placebo (normal saline) is administered.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Maryam Etminan
Street address
Afzalipoor Hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hssein Sattari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
hosattari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Etminan
Position
resident of anesthesia
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
javakrd34@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Etminan
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)