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Trial registered on ANZCTR
Registration number
ACTRN12612000921886
Ethics application status
Approved
Date submitted
24/08/2012
Date registered
29/08/2012
Date last updated
25/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
dexamethasone and tramadol as additives to local anesthetics in ultrasound guided supraclavicular brachial plexus (SCBP) block and duration of analgesia.
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Scientific title
The effect of tramadol or dexamethasone added to lidocaine for a ultrasound guided supraclavicular brachial plexus (SCBP) block on the onset, duration of sensory and motor blockade and first request of analgesia.
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Secondary ID [1]
281091
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nil
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Universal Trial Number (UTN)
U1111-1133-8023
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
analgesia after ultrasound guided nerve block
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Condition category
Condition code
Anaesthesiology
287571
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
15 ml lidocaine 2% + 8 mg dexamethasone in single shot ultrasound guided supraclavicular brachial plexus block.
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Intervention code [1]
285543
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Treatment: Drugs
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Comparator / control treatment
comparator group: 15 ml of lidocaine 2% + 2 ml tramadol (50 mg/ml = 100 mg) in single shot ultrasound guided supraclavicular brachial plexus block
control group: 15 ml of lidocaine 2% + 2 ml saline in single shot ultrasound guided supraclavicular brachial plexus block
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Control group
Active
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Outcomes
Primary outcome [1]
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Duration of postoperative analgesia:time interval between performing nerve block and the first analgesia request
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Assessment method [1]
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Timepoint [1]
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1, 3, 6, 12, and 24 h
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Primary outcome [2]
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and proportion of patients requiring analgesic supplementation for the first 24h
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Assessment method [2]
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Timepoint [2]
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24 hours
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Secondary outcome [1]
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Duration of sensory block was defined as the time between local anesthetic (LA) administration and the complete offset of sensory anesthesia on each nerve by pinprick test.
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Assessment method [1]
298899
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Timepoint [1]
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hourly for 24 hours
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Secondary outcome [2]
298953
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Duration of motor block was defined as the time from LA injection to score 5 of Bromage modified scale of each nerve.
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Assessment method [2]
298953
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Timepoint [2]
298953
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hourly for 24 hours
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Eligibility
Key inclusion criteria
patients undergoing upper limb wrist/hand/elbow or distal arm surgery
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
history of lung disease, obesity (body mass index > 30 kg/m2), a history of chronic pain or psychiatric disorder, drug or alcohol abuse, and hypersensitivity to local anesthetics
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
1/09/2012
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Actual
1/09/2012
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Date of last participant enrolment
Anticipated
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Actual
17/03/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Tunisia
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State/province [1]
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tunis
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Tunisian Military Hospital
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Address [1]
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20 Montfleury street, 1002, Tunis; Tunisia
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Country [1]
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Tunisia
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Primary sponsor type
Hospital
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Name
Tunisian Military Hospital
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Address
20 Montfleury street, 1002, Tunis; Tunisia
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Country
Tunisia
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Secondary sponsor category [1]
284703
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None
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Name [1]
284703
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Address [1]
284703
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Country [1]
284703
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287905
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tunisian military hospital local ethic comittee
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Ethics committee address [1]
287905
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20 Montfleury street, 1002, Tunis; Tunisia
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Ethics committee country [1]
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Tunisia
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Date submitted for ethics approval [1]
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15/08/2012
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Approval date [1]
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25/08/2012
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Ethics approval number [1]
287905
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Summary
Brief summary
During nerve blocks (which can control postoperative pain effectively), various drugs have been proposed in combination with local anesthetics (LA) to help reduce onset time and to prolong the duration of action and postoperative analgesia. Clonidine, epinephrine, and opioids are such examples but they are not without side effects.
Tramadol and dexamethasone was proposed as safe adjuvents to LA but there were no study comparing those two molecules in ultrasound guided (US) peripheral nerve blocks.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Trabelsi walid
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Address
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departement of anesthesia and intensive care unit, Tunisian Military Hospital, 20 Montfleury street 1002 Tunis; TUNISIA
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Country
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Tunisia
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Phone
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+21624091983
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Fax
34617
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof trabelsi walid
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Address
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departement of anesthesia and intensive care unit,Tunisian Military Hospital, 20 Montfleury street ,1002 Tunis; Tunisia
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Country
17864
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Tunisia
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Phone
17864
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+216 2409193
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Fax
17864
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Email
17864
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[email protected]
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Contact person for scientific queries
Name
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A/Prof trabelsi walid
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Address
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departement of anesthesia and intensive care unit,Tunisian Military Hospital, 20 Montfleury street ,1002 Tunis; Tunisia
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Country
8792
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Tunisia
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Phone
8792
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+2162409193
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Fax
8792
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Email
8792
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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