To determine the effect of Diclofenac suppositories in postoperative pain control, in removal of gallbladder. In a double-blind method, 60 patients with gallstones (which have no acute inflammation) are divided randomly into two groups . For first group diclofenac suppository is placed after Anesthesia and after recovery. In another group placebo is used. Postoperative pain is measured by Visual Analysis scale and the drug dose is calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009083384N4
Registration date:2011-02-21, 1389/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-21, 1389/12/02
Registrant information
Name
Ameneh Ebrahim Valoojerdi
Name of organization / entity
Endocrine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
info@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Diclofenac suppository on pain control in post laparoscopic cholecystectomy
Public title
Effect of Diclofenac suppository on pain control in post laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : Gallstone patients who referred to Rasoul Akram hospital
Exclusion Criteria: Acute backpack cystic , change intraoperative anesthetic protocol, having pain before surgery, pregnancy and breastfeeding, asthma or a known history of asthma, coagulopathy, history of upper or lower gastrointestinal bleeding during the past year, liver or kidney failure, history of sensitivity to NSAIDs , performed simultaneously with other gallbladder surgery, addiction to opiates or painkillers, duration of surgery more than 90 minutes
Age
No age limit
Gender
Both
Phase
3
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences , Hemat highway
City
Tehran
Postal code
Approval date
2010-06-27, 1389/04/06
Ethics committee reference number
890
Health conditions studied
1
Description of health condition studied
Diclofenac suppository on pain control in post laparoscopic cholecystectomy
ICD-10 code
K80-K87
ICD-10 code description
Disorders of gallbladder, biliary tract and pancreas
Primary outcomes
1
Description
Pain
Timepoint
Immediately after anesthesia - three hours later
Method of measurement
Visual Analisis Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Diclofenac suppository (100 mg) immediately after anesthesia and in three hours after recovery.
Category
Treatment - Drugs
2
Description
Control: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Maziar Moradi
Street address
Iranian university of Medical sciences , Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hossein saeidi motahar
Position
General sergeon
Other areas of specialty/work
Street address
Iran University of Medical Sciences , Hemat highy way
City
Tehran
Postal code
Phone
+98 21 6650 7055
Fax
Email
hsaeidimotahar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Saeidi Motahar
Position
General sergeon
Other areas of specialty/work
Street address
Iran University of Medical Sciences , Hemat highway
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
hsaeidimotahar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ameneh Ebrahim Valoojerdi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)