We studied the effect of oral acetazolamide in reducing post operation pain after laparoscopy cholecystectomy. This study was performed in 88 patients with cholelithiasis without any complication. The patients were randomly allocated into two groups. The two groups received 250mg oral Acetazolamide or placebo (2CC normal salin), every 8 hours, 24 hours before surgery. Abdominal and shoulder pain were measured by Mc Gill pain score before and after the surgery, during discharge from recovery and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902252428N5
Registration date:2010-06-08, 1389/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-08, 1389/03/18
Registrant information
Name
Maryam Rasty
Name of organization / entity
Shahrekord Univercity of Medicsal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
rasti@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of oral acetazolamide on the postoperative pain after laparoscopy cholecystectomy
Public title
Effect of oral acetazolamide on the postoperative pain after laparoscopy cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who are candidate for cholecystectomy by laparoscopic surgery. Exclusion criteria: Cholecystectomy with complications.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Shahrekord University of Medical Sciences
Street address
Aiatollahe Kashahni street
City
Shahrekord
Postal code
Approval date
2007-09-27, 1386/07/05
Ethics committee reference number
86-7-5
Health conditions studied
1
Description of health condition studied
cholecystitis without complication
ICD-10 code
K91.5
ICD-10 code description
Postcholecystectomy syndrome
Primary outcomes
1
Description
pain
Timepoint
before and after the surgery, during discharge from recovery and 24 hours after surgery
Method of measurement
Mc Gill pain Questionnaire
Secondary outcomes
1
Description
Narcotic drugs consumption as sedation
Timepoint
During hospitalization
Method of measurement
observation
Intervention groups
1
Description
Acetazolamide (oral), 250 mg, TDS, from 24 houres before surgery
Category
Treatment - Drugs
2
Description
2cc normal salin, TDS, from 24 hours before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Aiatollah Kashani hospital
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Dr. Hossein Yosefi
Street address
Aiatollah Kashahni street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University Of Medical Scences
Full name of responsible person
Dr. Mohammad Moazeni Bistgani
Position
Specialist in general surgery
Other areas of specialty/work
Street address
Ayatollah Kashani Hospital
City
Shahrekord
Postal code
Phone
+98 38 1222 4591
Fax
+98 38 1222 4492
Email
drmoazeni@skums.ac.ir & dr_m_moazeni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University Of Medical Sceinces
Full name of responsible person
Dr. Mohammad Moazeni Bistgani
Position
Specialist in general surgery
Other areas of specialty/work
Street address
Health Education Center Ayatollah Kashani
City
Shahrekord
Postal code
Phone
+98 38 1222 4591
Fax
+98 38 1222 4492
Email
drmoazeni@skums.ac.ir & dr_m_moazeni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Mohammad Moazeni Bistgani
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)