Background and aims: reduction of pain after Laparoscopic 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. Intervention group received 0.5mg/kg intraperitoneal bupivacain 0.5 % after Laparascopic cholecystectomy. Patients were evaluated in 0, 2, 4, 8, 12 and 24 hours after surgery. Primary outcome was pain reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090910790N1
Registration date:2012-10-24, 1391/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-24, 1391/08/03
Registrant information
Name
Banafshe Valiyan Borujeni
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 2422 2011
Email address
valian.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect evaluation of interaperitoneal injection of bupivacaine on post-operative pain in laparascopic cholecyctectomy
Public title
Effect evaluation of interaperitoneal injection of bupivacaine on post-operative pain in laparascopic cholecyctectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-60 years old patients selected by American Society of Anesthesiologists (ASA) sorting. Exclusion criteria: Total Body Weight (TBW) <50 kg; chronic pain or using opioid (in recently month); history of abdominal aneurysm.
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:
60
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
Ahwaz Jundishapour University of Medical Sciences
Street address
Ahwaz Razi hospital
City
Ahwaz
Postal code
Approval date
2012-06-14, 1391/03/25
Ethics committee reference number
536/د
Health conditions studied
1
Description of health condition studied
post-operative pain in laparascopic cholecyctectomy
ICD-10 code
K91.5
ICD-10 code description
Postcholecystectomy syndrome
Primary outcomes
1
Description
pain
Timepoint
0,1,2,8,12,24 hours after operation
Method of measurement
NRS
Secondary outcomes
1
Description
shoulder pain
Timepoint
0,1,2,8,12,24 hours after operation
Method of measurement
NRS
Intervention groups
1
Description
intervention group received, 0.5mg/kg intraperitoneal Bupivacain 0.25 % 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
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahwaz Jundishapour 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
Ahwaz Jundishapour 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
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Nozar Nasajian
Position
Assistant Professor
Other areas of specialty/work
Street address
Operation room,Golestan Khomeini hospital,Ahwaz
City
Ahwaz
Postal code
Phone
+98 6116193673166
Fax
Email
nozar-dr@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nozar Nasajian
Position
Assistant Professor
Other areas of specialty/work
Street address
Operation room, Golestan Khomeini hospital
City
Ahwaz
Postal code
Phone
+98 6116193673166
Fax
Email
nozar-dr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Banafshe Valiyan Borujeni
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Azadeghan st, Emam khomeini hospita
City
Ahwaz
Postal code
Phone
+98 38 2422 2011
Fax
Email
banafshe6937@yahoo.com ; valian.b@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)