Pain is prevalent after orthopedic surgery and it is necessary to find out a solution to control it. We evaluate the effect of buprenorphine in the control of pain after orthopedic surgery. One of the advantages of this drug is that, it is used sublingual and reduces the request of other analgesics. It has some complication such as nausea and vomiting and headache and vertigo. 186 individuals are randomly selected and divided into 3 groups. Inclusion criteria are age group of 15-65 and ASA class I, II and the patients who are candidate for limb's orthopedic surgery. Exclusion criteria are history of using analgesic and narcotic prior to the surgery; history of chronic lung and heart diseases; history of using Corticosteroids; history of using benzodiazepine. 0.4mg of sublingual buprenorphine, is given to 62 patient's 30 min before operation as A group. 0.4mg of sublingual buprenorphine, was given to 62 patient's, 30 min after operation as B group. 62 patients are taking 25mg pethedine after operation as control group. All 3 groups are identically anesthetised and are controlled each 2 hours to 12 hours and the results are listed in checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108292080N11
Registration date:2011-09-29, 1390/07/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-29, 1390/07/07
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of medical sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-09-08, 1390/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of buprenorphine in the control of pain after orthopedic surgery
Public title
The effect of buprenorphine in the control of pain after orthopedic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patient who are candidate for limb's orthopedic surgery and age group of 15-65 and ASA class I,II . Exclusion criteria: history of using analgesic and narcotic prior to the surgery; history of chronic lung and heart diseases; history of using Corticosteroids; history of using benzodiazepine.
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Alamol hoda street
City
Arak
Postal code
Approval date
2011-03-15, 1389/12/24
Ethics committee reference number
89-103-5
Health conditions studied
1
Description of health condition studied
orthopedic surgery
ICD-10 code
T01.2 ، T0
ICD-10 code description
Open wounds involving multiple body regions
2
Description of health condition studied
orthopedic surgery
ICD-10 code
T02.2 ، T0
ICD-10 code description
Fractures involving multiple body regions
3
Description of health condition studied
orthopedic surgery
ICD-10 code
T03.2 ، T0
ICD-10 code description
Dislocations, sprains and strains involving multiple body regions
Primary outcomes
1
Description
pain
Timepoint
every 2 hours
Method of measurement
VAS and check list and physical examination
Secondary outcomes
1
Description
nausea and vomitting
Timepoint
every 2 hours
Method of measurement
check list and physical examination
Intervention groups
1
Description
First group: 0.4 mg sub lingual buprenorphine, 30 min before operation
Category
Prevention
2
Description
Second group: 0.4 mg sub lingual buprenorphine, 30 min after operation
Category
Prevention
3
Description
Control group: 25 mg pethedine after operation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valieasr hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
Valiasr hospital, Emam khomeyni street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr.Changizi Ashtiyani
Street address
Alamol hoda street
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
Arak university of medical sciences
Full name of responsible person
Dr.Afsaneh Norouzi
Position
Asistant professor, Anesthesiologist
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Afsaneh Norouzi
Position
asistant professor, anesthesiologist
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
norouzi.a@arakmu.ac.ir , norouzi43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Samira Mohamadi
Position
Medical student
Other areas of specialty/work
Street address
Valieasr hospital, Emam khomeyni street
City
Arak
Postal code
Phone
+98 86 1224 7041
Fax
Email
mohamadi.samira.15@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)