Various drugs are administered intra-articularly to provide postoperative analgesia after total knee arthroplasty surgery. The purpose of this study was to assess the analgesic effects of intra-articular injection of a Dexmedetomidine following total knee arthroplasty.
Design
24 patients scheduled for total knee arthroplasty surgery under spinal anaesthesia, will be randomly devided into two groups. Patients will be divided into two groups by random number table. Intervention group will be received 1µg/kg dexmedetomidine and isotonic saline and control group received 25ml isotonic saline.
Settings and conduct
This double-blind randomized study will be conducted in the (C) operating room of Imam Khomeini Hospital in Orumiyeh.The syringes used are 5 ml and the surgeon will not know its content. Syringes containing drug and placebo in the two groups A and B will be prepared and labeled by someone else. After placing in the box randomly, a syringe with each sticker will be removed from the box and injected into the patient which was without the knowledge of the researcher and the patient and after completing the entire questionnaire, the researcher will be informed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with class I to III America society of Anesthesiologists؛ surgery with spinal anesthesia
Exclusion criteria: Cardiovascular disease؛ Neuropathic Disease؛ Previous surgery on the knee؛ Congenital deformity in the treated organ؛ Sensitivity to drugs used in the study؛ Arthroplasty for revision
Intervention groups
The purpose of this study was to assess the analgesic effects of intra-articular injection of a dexmedetomidine following total knee arthroplasty.Intervention group will be received 1µg/kg dexmedetomidine and isotonic saline and control group received 25ml isotonic saline.
Main outcome variables
Average postoperative pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160430027677N7
Registration date:2018-01-05, 1396/10/15
Registration timing:retrospective
Last update:2018-01-05, 1396/10/15
Update count:0
Registration date
2018-01-05, 1396/10/15
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of local Dexmedetomidine injection on post operative pain in total knee arthroplasty surgery
Public title
Clinical trial the effect of local Dexmedetomidine injection on post operative pain in patient with total knee arthroplasty surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with class I to III America society of Anesthesiologists; surgery with spinal anesthesia
Exclusion criteria:
Cardiovascular disease; Neuropathic Disease; Congenital deformity in the treated organ; Sensitivity to drugs used in the study; Arthroplasty for revision
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The syringes used are 5 ml and the surgeon will not know its content. Syringes containing drug and placebo in the two groups A and B will be prepared and labeled by someone else. After placing in the box randomly, a syringe with each sticker will be removed from the box and injected into the patient which was without the knowledge of the researcher and the patient and after completing the entire questionnaire, the researcher will be informed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Ershad Avenue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
ir.umsu.rec.1396.6
Health conditions studied
1
Description of health condition studied
Post operative pain
ICD-10 code
G90.529
ICD-10 code description
Complex regional pain syndrome I of unspecified lower limb
Primary outcomes
1
Description
Postoperative pain
Timepoint
In recovery, 6 and 12 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The average need for an analgesic drug to control pain
Timepoint
In 12 hours after surgery
Method of measurement
milligram
2
Description
The first time to apply for post-operative pain control
Timepoint
In 12 hours after surgery
Method of measurement
hour
3
Description
Postoperative bleeding is to 12 hours
Timepoint
In 12 hours after surgery
Method of measurement
Based on the amount of blood in the Hamovak donor, it is determined in 24 hours and the amount of hemoglobin in the postoperative patients.
4
Description
Sleep disorder after surgery
Timepoint
In 24hours after surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The study group will be received dexmedetomidine 1 micg/kg of body weight for dexamethasone
Category
Treatment - Drugs
2
Description
Control group: will be received 25 milliliter isotonic saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital, C operating room
Full name of responsible person
Shahryar Sane ,Associate Professor, Anesthesiologist