Purpose: This study is prospective, randomized, double-blinded and clinical trial. 44 patients candidate for diagnostic arthroscopic knee surgery were chosen and divided randomly to same groups. Method and intervention: The night before surgery and 2 hours before surgery all patient received 0.5 mgr Alprazolam for pre-medication. Patients were randomly assigned into two groups. The first group of patients 1 micro gram/kg of Dexmedetomidine with normal saline is intra articular injected. In group two 25cc of normal saline is intra articular injected.(The surgeon is blind about the type of drug ) Inclusion/exclusion criteria: Inclusion criteria: Age between 18 to 60 years; ASA I,II; Candidate arthroscopic knee surgery. Exclusion criteria: Renal failure; Hepatic failure; Ischemic heart failure; Blood pressure; Use narcotic or NSAIDs 24 hours before surgery; History of infection or cancer; Surgical time of more than an hour and a half; Excessive manipulation of the knee; Addiction; History of surgery; Need for a narcotic during opration. Primary and Secondary outcome: after surgery, the incidence of severity of pain, the onset time require the analgesic and
the average total dose of analgesic are evaluated with VAS in the first 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307274780N3
Registration date:2013-08-28, 1392/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-28, 1392/06/06
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-05-07, 1392/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraarticular injection of dexmedetomidine on postoperative pain in diagnostic arthroscopic knee surgery
Public title
The effect of intra articular injection of dexmedetomidine on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 60 years; ASA I,II; Candidate arthroscopic knee surgery. Exclusion criteria: Renal failur; Hepatic failure; Ischemic heart failure; Blood pressure; Use narcotic or NSAIDs 24 hours before surgery; History of infection or cancer; Surgical time of more than an hour and a half; Excessive manipulation of the knee; Addiction; History of surgery; Need for a narcotic during opration
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
Postal code
Approval date
2012-12-01, 1391/09/11
Ethics committee reference number
3354
Health conditions studied
1
Description of health condition studied
postoperative pain in diagnostic arthroscopic knee surgery
ICD-10 code
M23.6
ICD-10 code description
Other spontaneous disruption of ligament(s) of knee
Primary outcomes
1
Description
Severity of pain
Timepoint
1, 3, 12 and 24 h after Surgery
Method of measurement
VAS
Secondary outcomes
1
Description
Analgesic onset time
Timepoint
1 hour after surgery to 24 hours later
Method of measurement
Verbal analogue scale
2
Description
Total dose of analgesic
Timepoint
1 hour after surgery to 24 hours later
Method of measurement
Verbal analogue scale
Intervention groups
1
Description
Intra articular injection after surgery(1 ml/kg dexmedetomidine with normal saline
Category
Treatment - Drugs
2
Description
control group: Intra articular 25cc normal saline injection after surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Mohammad Alipour
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Dr Tavakol Afshar
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
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, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm.mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
alipourm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)