This study is a double-blind randomized clinical trial (RCT). Ileus is a common problem in postoperative period which complicates many of abdominal operations. Lower rates of ileus in Spinal or Epidural anesthesia comparing with General anesthesia made the hypothesis that the systemic absorbtion of Lidocaine or other local anesthetic agents, may be the cause.So 62 patients which had undergone laparotomies due to various reasons, were divided randomly in two groups, as Lidocaine receivers or Controls. The bolus dose of Lidocaine or placebo were injected intravenously at extubation time.The dose of Lidicaine was 1.5mg/kg and then continued with 1mg/kg/hour for 24 hours. Data were analysed by SPSS 16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061213656N1
Registration date:2013-07-07, 1392/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-07, 1392/04/16
Registrant information
Name
Seyed Muhammad Mehdi Ghaffari Hamedani
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 32 07838
Email address
muhammadghaffari@irimc.org
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of IV Lidocaine on post laparotomic ileus
Public title
Impact of IV Lidocaine on post laparotomic ileus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients undergoing laparotomy
Exclusion criteria: history of substance abuse, loss of consciousness, dementia, resection and anastamosis of GI during surgery, presence of chemical or fecal peritonitis as the cause of laparotomy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
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
48175-688
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
89-171
Health conditions studied
1
Description of health condition studied
Ileus
ICD-10 code
K56.0
ICD-10 code description
Paralytic ileus
Primary outcomes
1
Description
Gas passage or defecation
Timepoint
Postoperative period
Method of measurement
postoperative questionnaire
Secondary outcomes
1
Description
Nausea
Timepoint
Postoperative period
Method of measurement
Postoperative quistionnaire
2
Description
Vomiting
Timepoint
Postoperative period
Method of measurement
Postoperative quistionnaire
3
Description
Score of pain
Timepoint
Postoperative period
Method of measurement
Postoperative quistionnaire
4
Description
Appetite
Timepoint
postoperative period
Method of measurement
postoperative quistionnaire
5
Description
starvation
Timepoint
postoperative period
Method of measurement
postoperative quistionnaire
Intervention groups
1
Description
bolus dose of intravenous Lidocaine 1.5mg/kg and following by maintenance dose of Lidocaine 1mg/kg/h
Category
Prevention
2
Description
bolus dose of intravenous normal saline 1.5cc/kg and following by maintenance dose of normalsaline 1cc/kg/h
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini General Hospital
Full name of responsible person
Seyed Muhammad Mehdi Ghaffari Hamedani, MD
Street address
Surgery department of Imam Khomeini Hospital
City
Sari
2
Recruitment center
Name of recruitment center
Boali Sina Hospital
Full name of responsible person
Seyed Muhammad Mehdi Ghaffari Hamedani, MD
Street address
Surgery department of Imam Khomeini Hospital
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
Dr Ahmad Ali Enayati
Street address
Mazandaran university of medical sciences, Moallem Square, Sari, Iran Sari Mazandaran Iran, Islamic Republic Of
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
Seyed Muhammad Mehdi Ghaffari Hamedani
Position
General & digestive surgeon
Other areas of specialty/work
Street address
Surgery department of Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 26 2225 6329
Fax
+98 15 1225 6329
Email
muhammadghaffari@irimc.org; ghaffari99@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Seyed Muhammad Mehdi Ghaffari Hamedani
Position
General & digestive surgeon
Other areas of specialty/work
Street address
Surgery department of Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 15 1225 6329
Fax
+98 15 1225 6329
Email
muhammadghaffari@irimc.org; ghaffari99@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
Seyed Muhammad Mehdi Ghaffari Hamedani
Position
General & digestive surgeon
Other areas of specialty/work
Street address
Surgery department of Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 15 1225 6329
Fax
+98 15 1225 6329
Email
muhammadghaffari@irimc.org; ghaffari99@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)