Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand
The purpose of the study : Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand. Method: Double blind randomized clinical trial. Sample size: 78. Inclusion criteria: Consent to participate in research project and cooperation for axillary block; No addiction to opium, Benzodiazepine, Clonidine; Absence of liver and kidney failure, diabetes, cardiovascular and lung diseases, coagulopathy; Lack of any allergic history to local anesthetics; No use of opium in the past 48 hours; Absence of anatomical deformity or burning or infection in block region; No pregnancy in female patients.
Exclusion criteria: The unwillingness or lack of cooperation from the patient during surgery. Study groups: 1) Group receiving lidocaine + Ketamine 2) Group receiving lidocaine +Dexamethasone 3) Group receiving lidocaine. Measurement and recording of variables: 1) Measuring onset of sensory and motor block every three minutes to complete the block and recording it 2) Measuring and Recording duration of sensory and motor block after the completion of surgery every three minutes. Data analysis: Data will be analyzed with statistical tests by using SPSS software, version 22.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030132837N1
Registration date:2017-04-20, 1396/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-20, 1396/01/31
Registrant information
Name
Behrooz Zaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
zaman.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanceler for research, Iran university of medical sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-04, 1396/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand
Public title
Comparison of the effect of Ketamine and Dexamethasone in combination with Lidocaine on the onset and duration of Axillary block in soft tissue surgery of forearm and hand
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Consent to participate in research project and cooperation for axillary block; No addiction to opium, Benzodiazepine, Clonidine; Absence of liver and kidney failure, diabetes, cardiovascular and lung diseases, coagulopathy; Lack of any allergic history to local anesthetics; No use of opium in the past 48 hours; Absence of anatomical deformity or burning or infection in block region; No pregnancy in female patients.
Exclusion criteria: The unwillingness or lack of cooperation from the patient during surgery.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
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
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2016-04-05, 1395/01/17
Ethics committee reference number
IR.IUMS.REC.1394.9211174004
Health conditions studied
1
Description of health condition studied
Soft tissue injury of forearm and hand
ICD-10 code
S50, S51,
ICD-10 code description
Superficial injury of forearm, Open wound of forearm, Injury of nerves at forearm level,Injury of blood vessels at forearm level, Injury of muscle and tendon at forearm level, Superficial injury of wrist and hand, Open wound of wrist and hand, Injury of
Primary outcomes
1
Description
Onset of sensory block
Timepoint
every 3 minutes
Method of measurement
Measuring the length of time between the last injection until complete disappearance of any sense of touch with the stopwatch
2
Description
onset of motor block
Timepoint
every 3 minutes
Method of measurement
Measuring the length of time between the last injection to complete motor paralysis with Stopwatch
3
Description
Duration of sensory block
Timepoint
every 3 minutes
Method of measurement
Measuring the time between onset of complete sensory block until the complete return again sense organs with Stopwatch
4
Description
duration of motor block
Timepoint
every 3 minutes
Method of measurement
Measuring the time between onset of complete paralysis to return of complete movement power with stopwtch
Secondary outcomes
1
Description
Diastolic blood pressure
Timepoint
0, 5, 10, 15, 20, 25 minutes after Axillary block
Method of measurement
Non-invasive automatic sphygmomanometer
2
Description
Systolic blood pressure
Timepoint
0, 5, 10, 15, 20, 25 minutes after Axillary block
Method of measurement
Non-invasive automatic sphygmomanometer
3
Description
Pulse rate
Timepoint
0, 5, 10, 15, 20, 25 minutes after Axillary block
Method of measurement
ECG monitoring
4
Description
Nystagmus
Timepoint
0, 5, 10, 15, 20, 25 minutes after Axillary block
Method of measurement
Find the rapid movements of the eyes of horizontal reciprocating
Intervention groups
1
Description
The intervention group 1 : Axillary block with 38 cc lidocaine 1% in combination with dexamethasone 8 mg in 2 ml
Category
Other
2
Description
The intervention group 2 : Axillary block with 38 cc Lidocaine 1% combination with 50 mg of Ketamine in 2 cc
Category
Other
3
Description
Control group :
Axillary block with 38 cc lidocaine 1% in combination with 2 mL of saline
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Siavash Hojjati Ashrafi
Street address
23 St, Asad abadi St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanceler for research, Iran university of medical sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanceler for research, Iran 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
Hazrat Fatemeh Hospital
Full name of responsible person
Dr Behrooz Zaman
Position
Anesthesiologist / Assistant Professor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
23 St, Asad abadi St, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 0099
Fax
Email
behroozzaman@gmail.com
zaman.b@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hazrat Fatemeh Hospital
Full name of responsible person
Dr Behrooz Zaman
Position
Anesthesiologist/ Assistant Professor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
23 St,Asad abadi St, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 0099
Fax
Email
behroozzaman@gmail.com zaman.b@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hazrat Fatemeh Hospital
Full name of responsible person
Dr Behrooz Zaman
Position
Anesthesiologist / Assistant Professor of Iran University of Medical Sciences
Other areas of specialty/work
Street address
23 St, Asad abadi St, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 0099
Fax
Email
behroozzaman@gmail.comzaman.b@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)