Protocol summary
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Study aim
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Dexamethasone Compared with Dexmedetomidine as an adjuvant to Bupivacaine for Supraclavicular Brachial Plexus Block
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Design
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Double Blinded Randomized Clinical Trial
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Settings and conduct
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In the operating theater of Chamran hospital ,patients in the intervention group one receive 24 ml of bupivacaine(bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 1 ml of dexamethasone (4 mg) for supraclavicular block.
In the second group, patients receive 24 ml of bupivacaine (bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 0.5 ml of doxedemotomidine (50 μg) for supraclavicular block.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:Age 21 to 60 years old , Fractures of the forearm surgeries under supraclavicular plexus block.
Exclusion Criteria: Heart disease ,Patients with high blood pressure, Bradycardia ,Hyperthyroidism ,Cardiac Blocks of Grade 1,2,3 ,Use of adrenoreceptor agonist and antagonist ,Peripheral neuropathy ,pregnant women, Patients who are addicted to narcotics and stimulant drugs ,Patients susceptible or allergic to the drugs , Coagulation disorders, Local infections, Patient refusal
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Intervention groups
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Patients in the intervention group one receive 24 ml of bupivacaine(bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 1 ml of dexamethasone (4 mg) for supraclavicular block.
In the second group, patients receive 24 ml of bupivacaine (bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 0.5 ml of doxedemotomidine (50 μg) for supraclavicular block.
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Main outcome variables
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Duration of sensory block, Onset of the sensory block,Duration of the motor block,Onset of the motor block
General information
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Reason for update
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Due to several refereeing corrections at the time of registration, the expected recruitment start date has not been corrected in the last refereeing. Please, change expected recruitment start date two months later
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N84
Registration date:
2019-07-30, 1398/05/08
Registration timing:
prospective
Last update:
2021-02-13, 1399/11/25
Update count:
1
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Registration date
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2019-07-30, 1398/05/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-15, 1398/06/24
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Expected recruitment end date
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2019-10-29, 1398/08/07
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Dexamethasone Compared with Dexmedetomidine as an adjuvant to Bupivacaine for Supraclavicular Brachial Plexus Block
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Public title
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Dexamethasone Compared with Dexmedetomidine as an adjuvant to Bupivacaine for Supraclavicular Brachial Plexus Block
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 21 to 60 years old
Fractures of the forearm surgeries under supraclavicular plexus block
Exclusion criteria:
Heart disease
Patients with high blood pressure
Bradycardia
Hyperthyroidism
Cardiac Blocks of Grade 1,2,3
Use of adrenoreceptor agonist and antagonist
Peripheral neuropathy
pregnant women
Patients who are addicted to narcotics and stimulant drugs
Patients susceptible or allergic to the drugs studied
Coagulation disorders
Local infections
Patient refusal
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Age
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From 21 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomly divided into two groups according to the table provided by Randomization.com and using Random permutations.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The same syringes containing 1 ml of dexamethasone or 1 ml of dexamethasone (0.5 cc dexamethasone diluted with half a cc distilled water), which are provided by a researcher, syringes are labeled only with the number, and the investigator dose not intervene in the Supraclavicular Brachial Plexus Block .
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-25, 1396/08/03
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Ethics committee reference number
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IR.SUMS.MED.REC.1396.121
Health conditions studied
1
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Description of health condition studied
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Forearm bones fracture
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ICD-10 code
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M96.63
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ICD-10 code description
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Fracture of radius or ulna following insertion of orthopedic implant, joint prosthesis, or bone plate
Primary outcomes
1
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Description
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Duration of sensory block
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Timepoint
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15 and 30 minutes after entering the recovery and 1,2,4,6,12,18,24 in the ward
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Method of measurement
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pinprick
2
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Description
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Onset of the sensory block
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Timepoint
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At 0.1, 5. 10, 15, 20, 25 and 30 min after the injection of anesthetics
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Method of measurement
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pinprick
3
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Description
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Duration of the motor block
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Timepoint
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15 and 30 minutes after entering the recovery and 1,2,4,6,12,18,24 in the ward
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Method of measurement
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Bromage
4
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Description
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Onset of the motor block
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Timepoint
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15 and 30 minutes after entering the recovery and 1,2,4,6,12,18,24 in the ward
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Method of measurement
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Bromage
Intervention groups
1
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Description
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Intervention group: Patients in the intervention group one receive 24 ml of bupivacaine(bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 1 ml of dexamethasone (4 mg)(Caspian, Iran) for supraclavicular block.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: In the second group, patients receive 24 ml of bupivacaine (bupivacaine,Mylan,A.S.A, France)( 0.5%) plus 0.5 ml of doxedemotomidine (Hospiar,INC,Lake Forest, USA) (50 μg) for supraclavicular block.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available