Background and aims In this clinical trial : reduction of post surgery nausea and vomiting after Laparascopic cholecystectomy . inclusion criteria: 20-60 years old without diabetes mellitus, hypertension, congenital or acquired heart disease.exclusion criteria : duration of surgery more than 2 hours, another operation at the same time, complication in or after operation .age:20-60. 50 patient entered in our study . intervention group received, 0.5mg/kg intraperitoneal bupivacain 0.5 % after Laparascopic cholecystectomy .patient evaluated in 1,2,6 and 12 hour after surgery .primary measurement is reduction of nausea and vomiting .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110287928N1
Registration date:2012-04-22, 1391/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-22, 1391/02/03
Registrant information
Name
Hedieh Daneshyar
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1822 8446
Email address
daneshyar.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2009-07-26, 1388/05/04
Expected recruitment end date
2010-04-24, 1389/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intraperitoneal injection of Bupivacain0.5% in post operation nausea and vomiting in laparascopic cholecystectomy
Public title
Evaluation of the effect of intraperitoneal injection of Bupivacain 0.5% in post operation nausea and vomiting in laparascopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: 20-60 years old without diabetes mellitus, hypertension, congenital or acquired heart dieses
exclusion critreria: duration of surgery more than 2 hours, another operation at the same time, complication in or after operation
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
7928
Secondary trial Id
Eth013
Registration date
2012-01-04, 1390/10/14
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapour University of Medical Science
Street address
Shaher daneshgah
City
Ahvaz
Postal code
Approval date
2011-06-27, 1390/04/06
Ethics committee reference number
262/د
Health conditions studied
1
Description of health condition studied
nausea and vomiting resolve after laparscopic cholecystectomy
ICD-10 code
K91.5
ICD-10 code description
Postcholecystectomy syndrome
Primary outcomes
1
Description
nausea
Timepoint
1hrs,2hrs,6hrs,12hrs after surgery
Method of measurement
VAS
Secondary outcomes
1
Description
vomiting
Timepoint
1hrs,2hrs,6hrs,12hrs after surgery
Method of measurement
VAS
Intervention groups
1
Description
intervention group received, 0.5mg/kg intraperitoneal Bupivacain 0.5 % after Laparascopic cholecystectomy
Category
Treatment - Drugs
2
Description
control group received 0.5 cc/kg , normal salin after Laparascopic cholecystectomy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Reza Akhond zade
Position
assistant professor
Other areas of specialty/work
Street address
Operation room, Imam Khomeini hospital
City
Ahwaz
Postal code
Phone
6193673166 -00986112222114
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Mohtadi
Position
assistant professor
Other areas of specialty/work
Street address
Imam khomini Hospital, Azadegan St.
City
Ahwaz
Postal code
Phone
+98 61 9367 3166
Fax
Email
mohtadi_dr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hedieh Daneshyar
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Imam khomini hospital, Azadegan St.
City
Ahwaz
Postal code
Phone
Fax
Email
dr.h.daneshyar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)