Comparison of post operative analgesic effect of adding Dexmedetomidine or dexamethasone to lidocaine through infraclavicular block in forearm surgery.
The purpose of this study is evaluation the effects of Dexmedetomidine and dexamethasone as Local anesthetic adjuvant on the onset and duration of Infraclavicular Brachial plexus block under sonograhy guided thechnique. This study is a one centric randomized controlled trial that will be implemented on 75 patients 20-60 years old candidate for elective elective forearm surgeries with Infraclavicular Brachial plexus block that are scheduling in class 1 and 2 Society of Anesthesiology America. Patients will be divided into three 25 groups by simple randomized method (closed packet and the selection of painted cards). in group1:28 cc lidocaine 1.5% plus 2cc distilled water, group2:28 cc lidocaine 1.5% plus 8mg Dexamethasone and group3:28 cc lidocaine 1.5% plus 1µgr/kg Dexmedetomidine will administer. In three groups, sensory and motor block onset time and duration of them, hemodynamic Variables, pain severity (VAS Score) and administration of analgesics and overall analgesic requirement within in 2, 4 and 6 hours after infraclavicular block will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011423473N2
Registration date:2016-06-06, 1395/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-06, 1395/03/17
Registrant information
Name
Siamak Yaghuobi
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
syaghoubi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post operative analgesic effect of adding Dexmedetomidine or dexamethasone to lidocaine through infraclavicular block in forearm surgery.
Public title
Comparison of post-operative analgesic effect of adding Dexmedetomidine or dexamethasone to lidocaine through local anastasia in forearm surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients 20–60 years old; with American Society of Anesthesiologists (ASA) physical status I or II; scheduled for elective forearm surgery.
Exclusion criteria: Presence of underlying diseases such as coagulopathy, peripheral vascular diseases and neuropathy; patient’s avoidance; any history of allergy to local anesthetics; treatment with palliative drugs and those affecting the CNS; addiction; neurologic deficit in respective organ; infection in the site of injection; pregnancy; BMI˂20 & BMI>40; the use of drugs which interfere with lidocaine such as beta blockers, cimetidine, phenytoin.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Ethics Committee of the University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
3419759811
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
IR.QUMS.REC.1394.278
Health conditions studied
1
Description of health condition studied
Forearm laceration
ICD-10 code
S54, S56
ICD-10 code description
Injury of nerves at forearm level, Injury of muscle and tendon at forearm level
Primary outcomes
1
Description
Pain
Timepoint
In 2, 4 and 6 hours after infraclavicular block
Method of measurement
Visual analogue Scales(VAS)
2
Description
Total analgesic dose administered
Timepoint
During 6 hrs after the infraclavicular block ( With interval 2hrs)
Method of measurement
Patient file
Secondary outcomes
1
Description
Onset of sensory and motor block
Timepoint
From the start of anesthetics injection
Method of measurement
Evaluate the patient’s response to needle hitting on surgical site and griping force
2
Description
Time of duration of sensory block
Timepoint
The time interval between the time of loss of pain sensation at forearm to reappearance of paresthesia
Method of measurement
Pin-prick test
3
Description
Hemodynamic variables of the block
Timepoint
In 5, 10, 15, 20 and 30 minutes after infraclavicular block
Method of measurement
Monitoring system
4
Description
Time of duration of motor block
Timepoint
The time interval between the time of loss of pain sensation at forearm to complete recovery of motor function.
Method of measurement
Gripping force test
Intervention groups
1
Description
In group 1, 28 cc lidocaine 1.5% plus 2cc distilled water will administer.
Category
Placebo
2
Description
In group 2, 28 cc lidocaine 1.5% plus 8mg Dexamethasone will administer
Category
Prevention
3
Description
In group 3, 28 cc lidocaine 1.5% plus 1μgr/kg Dexmedetomidine will administer.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajee Hospital
Full name of responsible person
Dr. Hoda Shehamat
Street address
Rajee Hospital, Padegan Avenu, Qzvin.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hoda Shehamat
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qzvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
hoda_shahamat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr. Siamak Yaghoubi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital ; Padegan Avenu ; Qzvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
Drsiamakyaghoubi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hoda Shahamat
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital ; Padegan Avenu ; Qzvin
City
Qazvin
Postal code
Phone
+98 28 3332 0105
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)