The comparison effects of intraarticular injection opioids (morphine, tramadole, methadone and pethidine) on postoperative pain relief after knee surgery (anterior cruciate ligament reconstruction)
The aim of this study is to compare analgesic effect of intraarticular injection of opiodes after knee surgery. This study will be done as a double-blind randomized controlled clinical trial on 150 patients. Inclusion criteria are: ASAI or ASAII class of American Society of Anesthesiologist; Age range of 18-65 years old; Tolerance to general anesthesia and sign of informed consent. Exclusion criteria are: history of allergic reaction to administered drugs; history of drug abuse; history of chronic pain; consumption of MAOI agent; using preoperative opioids or other analgesic drugs . 150 patients will be recruited in five groups randomly. All of them receive an intraarticular injection contained 9.5 ml bupivacain with 1:200,000 epinephrine, at the end of surgery in a 10ml syringe. The remainder of syringe is filled with one of the below solution: Group I, 5 mg methadone; Group II, 5 mg morphine; Group III, 37.5 mg pethidine; Group IV, 100 mg tramadol; Group V, 0.5 ml normal saline. Then patients receive analgesic based on their needs every 4 hours. The patients need to analgesics during first 12 hours (every 4 hours) after hospitalization, and pain score based on VSA are measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106102341N4
Registration date:2011-09-04, 1390/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-04, 1390/06/13
Registrant information
Name
Hamidreza Arti
Name of organization / entity
Ahvaz Jundishapour University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 9092
Email address
arti@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord and Ahvaz Uniuversity Of Medical Sciences
Expected recruitment start date
2005-03-21, 1384/01/01
Expected recruitment end date
2007-03-21, 1386/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effects of intraarticular injection opioids (morphine, tramadole, methadone and pethidine) on postoperative pain relief after knee surgery (anterior cruciate ligament reconstruction)
Public title
The comparison effects of intraarticular injection opioids (morphine, tramadole, methadone and pethidine) on postoperative pain relief after knee surgery (anterior cruciate ligament reconstruction)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate of ruptured knee ACL reconstruction ; ASAI or ASAII class of American society of Anesthesiologist; Age between 18- 65 years old; Tolerance to general anesthesia and sign of informed consents. Exclusion criteria: history of allergic reaction to administered drugs in this study; history of drug abuse; history of chronic pain; consumption of MAOI agent ; using preoperative opioids or other analgesic drugs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Kashani Bulvard
City
Shahrekord
Postal code
8815713470
Approval date
2006-05-22, 1385/03/01
Ethics committee reference number
3-2-58
Health conditions studied
1
Description of health condition studied
pain after knee anterior cruciate ligament reconstruction
ICD-10 code
M24.2
ICD-10 code description
Instability secondary to old ligament injury
Primary outcomes
1
Description
pain after knee anterior cruciate ligament reconstruction
Timepoint
every 4 hours
Method of measurement
visual analouge score
Secondary outcomes
1
Description
pain relief and reduction of need to analgesics
Timepoint
every 4 hours
Method of measurement
visual analouge score
Intervention groups
1
Description
Morphine group receives 0.5% bupivacaine with 1:200,000 epinephrine and 5mg morphine
Category
Treatment - Drugs
2
Description
Methadone group receives 0.5% bupivacaine with 1:200,000 epinephrine and 5mg methadone
Category
Treatment - Drugs
3
Description
Pethidine group receives 0.5% bupivacaine with 1:200,000 epinephrine and 37.5 mg Pethidine
Category
Treatment - Drugs
4
Description
Tramadol group receives 0.5% bupivacaine with 1:200,000 epinephrine and 100 mg Tramadol.
Category
Treatment - Drugs
5
Description
Control group receives 0.5% bupivacaine with 1:200,000 epinephrine 0.5 ml normal saline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital of Shahrekord
Full name of responsible person
Dr. Hamidreza Arti
Street address
Varzesh St.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord university of Medical Sciences/ Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Kashani Bulvard, Vice Chanceller for Research of Shahrekord University of Medical Sciences
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/ Ahvaz Jundishapour 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 Sciences
Full name of responsible person
Dr. Mahmood Mobasheri
Position
Epidemiologist
Other areas of specialty/work
Street address
Vice Chanceller for Reaserch, Kashani Blvrd
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1334 2414
Fax
+98 38 1334 9506
Email
pajoohesh@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Hamidreza Arti
Position
Orthopaedic Specialist, associated Professor of Ahvaz Jundishapur University Of Medical Sciences
Other areas of specialty/work
Street address
Emmam Khomeini Hospital, Orthopaedic Department, Azadegan St
City
Ahvaz
Postal code
7463588739
Phone
+98 61 1338 7481
Fax
Email
hamidrezaarti@gmail.com ; artihamidreza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Hamidreza Arti
Position
Orthopaedic Specialist, associated Professor
Other areas of specialty/work
Street address
Emmam Khomeini Hospital, Orthopaedic Department, Azadegan St
City
Ahvaz
Postal code
7463588739
Phone
+98 61 1338 7481
Fax
Email
hamidrezaarti@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)