The goal of this double blind study is comparison of suppository morphine and intravenous pethidine on postoperative pain after laparoscopic cholecystectomy surgery. Participants are 20-60 years old patients in American Society of Anesthesiologists (ASA) classes 1 or 2 candidate for laparoscopic cholecystectomy surgery. 46 patients divided to two equal groups of morphine and pethidine . Sensitivity to the opioids, liver or kidney failure, the consumption of opioid before surgery, acute respiratory failure, the consumption of mono amin oxidase (MAO) enzyme inhibitor drugs at the same time or during the last 14 days ago are exclusion criteria. All patients receive a same general anesthesia tecnique. At the end of anesthesia and before reverse time, one group receives 10 mg suppository morphine and other group receives 20 mg intravenous pethidine . Pain intensity measures with Visual Analog Scale (VAS) during 6 hours after surgery. The first analgesic request will compare in both groups. At the end, satisfaction from quality of pain relief records as: poor, moderate, well and excellent.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712295N1
Registration date:2013-11-28, 1392/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-28, 1392/09/07
Registrant information
Name
Reza Baghbanian
Name of organization / entity
Ahvaz Jundishapur Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
baghbanian.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of suppository morphine and intravenous pethidine on postoperative pain after laparoscopic cholecystectomy surgery
Public title
Comparison of suppository morphine and intravenous pethidine on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the age of 20 to 60 years; weight of 70 to 90 Kg; candidate of laparascopic cholecystectomy; anesthesia risk 1 or 2 Exclusion criteria: sensitivity to the opioids; liver or kidney failure; the consumption of opioid before surgery; acute respiratory failure; the consumption of mono amin oxidase(MAO) enzyme inhibitor drugs at the same time or during the last 14 days ago
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double-blind because patients and person who evaluate the pain intensity are not aware about interventions. In this study we uses single dose suppository morphine(10 mg) produce in Hamblen CO,Germany and intravenous pethidine(20 mg) produce in Aboureyhan CO,Iran At the enf of surgery.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv.
City
Ahvaz
Postal code
Approval date
2012-12-19, 1391/09/29
Ethics committee reference number
Eth- 671
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Postoperative Pain
Timepoint
0 , 1 , 2 , 4 and 6 hours after extubation
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Amount of received opioid after surgery for pain control
Timepoint
during 48 hours after surgery
Method of measurement
Milligram
Intervention groups
1
Description
In first intervention group ,use of 10 mg suppository morphine at the end of surgery and before extubation.
Category
Treatment - Drugs
2
Description
In the second intervention, use of 20 mg intravenous pethidine at the end of surgery and before extubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Reza Baghbanian
Street address
Palestin Avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Golestan Blv.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
School of Medicine, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
Baghbanian.r@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Medicine, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Pourmehdi
Position
Assistant Professor of Anesthesia
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
Pourmehdi.z@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine , Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
+98 61 1222 0168
Email
Baghbanian.r@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)