The purpose of this study was to determine the effect of methocarbamol on the pain of post- cholecystectomy surgery. In a randomized, double-blind clinical trial, 60 ASA class 1-2 patients between 30 and 50 years old with weight lower than 100kg, undergoing general anesthesia for cholecystectomy elective surgery in Besat Hospital were recruited. Both groups didn’t receive any premedication. Under similar general anesthesia, the patients in one group received 500mg Methocarbamol, IV slowly, and the other group received 5cc placebo IV slowly, after the operation. The pain intensity were compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101124505N2
Registration date:2011-02-07, 1389/11/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-02-07, 1389/11/18
Registrant information
Name
Rasool Kavyannejad
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 5322 3828
Email address
rasol.kavian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Kordestan University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-06-12, 1390/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effect of metocarbamol on postoperative pain after cholecystectomy
Public title
Effect of metocarbamol on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1-2, age between 30-50 years old, weight lower than 100kg, undergoing general anesthesia for cholecystectomy elective surgery
Exclusion criteria: presence of systemic illness such as lung, kidney, or heart diseases, smoking, presence of side effects to the study drug, incidence of side effect such as lung and heart reactions, consumption of other drugs affecting pain
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
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
Kordestan University of Medical Sciences
Street address
Pasdaran Street, Sanandaj
City
Sanandaj
Postal code
Approval date
2007-12-26, 1386/10/05
Ethics committee reference number
4644
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
Pain
Timepoint
1, 3, 6, 12 hours
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Metocarbamol 500mg, IV slowly, diluted in 5 cc normal saline
Category
Treatment - Drugs
2
Description
Control group: normal saline, 10 cc, IV slowly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Rasol Kavyannejad
Street address
Eghbal square
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kordestan University of Medical Sciences and Health Services
Full name of responsible person
Kordestan University of Medical Sciences and Health Services
Street address
Pasdaran street
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kordestan University of Medical Sciences and Health Services
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
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Rasol Kavyannejad
Position
Msc student in critical care nursing
Other areas of specialty/work
Street address
Mahdie street
City
Hamedan
Postal code
Phone
+98 918 969 9149
Fax
Email
rasol.kavian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Rasol kavyannejad
Position
Msc student in critical care nursing
Other areas of specialty/work
Street address
Mahdia street
City
Hamedan
Postal code
Phone
+98 918 969 9149
Fax
Email
rasol.kavian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rasol Kavyannejad
Position
Msc student in critical care nursing
Other areas of specialty/work
Street address
Mahdia street
City
Hamedan
Postal code
Phone
Fax
rasol.kavian@umsha.ac.ir
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)