For this reason we decided to compare intrapritoneal bupivacine and mepridine with intravenous analgesics to prevent post operation pain.This study is interventional clinical trial.90 patient with symptomatic gallstones were divided in to 3 equal groups.In the first group we injected 40 ml of 0.25 % bupivacaine intrapritoneally.The second group received 25 mg of Petedin diluted in 40 ml normal saline interapretoneally.The third group treated with interavenous analgesics.Inclusion criteria:20-75 years, gall stone without symptom, no history of heart disease, lung and kidney, impassibility Bupivacine and Petedin.Exclusion criteria: Gallstones complicated, allergy to bupivacine, Heart failure class 3 and 4, end stage renal disease, Open cholecystectomy ,addiction.Post operation pain was assessed with visual analogue scale at 0 , 6, 12 and 24 hours after sugery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030120258N3
Registration date:2016-03-07, 1394/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare intra pritoneal Bupivacine and Petedin with intravenous analgesics to prevent post operation
Public title
Compare intra pritoneal Bupivacine and Petedin with intravenous analgesics to prevent post operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:20-75 years; gall stone without symptom; no history of heart disease; lung and kidney; impassibility Bupivacine and Petedin
Exclusion criteria: Gallstones complicated; allergy to bupivacine; Heart failure class 3 and 4; end stage renal disease; Open cholecystectomy ;addiction
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Postal code
848176941
Approval date
2012-09-03, 1391/06/13
Ethics committee reference number
91-132-7
Health conditions studied
1
Description of health condition studied
cholecystectomy
ICD-10 code
k81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Pain
Timepoint
after operation,6 hours after operation,12hours after operation,24 hours after operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Nausa and vomitting
Timepoint
after operation,6 and 12 and 24 hours after operation
Method of measurement
Observation
Intervention groups
1
Description
first group intervention we injected 40 ml of 0.25 % bupivacaine intrapritoneally
Category
Treatment - Drugs
2
Description
Second group intervention received 25 mg of Petedin diluted in 40 ml normal saline interapretoneally
Category
Treatment - Drugs
3
Description
Third group treated with interavenous analgesics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Shahin Fateh
Street address
Arak, Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Valiasr Hospital
Full name of responsible person
Dr Shahin fateh
Position
Professor of Thorax
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
dr.norouziAzrzkmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicine Department
Full name of responsible person
Dr Shahin Fateh
Position
Professor of Thorax
Other areas of specialty/work
Street address
Reaserch Center, Payambar Azam Complex, Basij Square, , Sardasht,Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
dr.norouzi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Shahin Fateh
Position
Professor Of Thorax
Other areas of specialty/work
Street address
Reaserch Center, Payambar Azam Complex, Basij Square, , Sardasht,Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)