Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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.
Secondary ID [1] 281091 0
nil
Universal Trial Number (UTN)
U1111-1133-8023
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
analgesia after ultrasound guided nerve block 287246 0
Condition category
Condition code
Anaesthesiology 287571 287571 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 ml lidocaine 2% + 8 mg dexamethasone in single shot ultrasound guided supraclavicular brachial plexus block.
Intervention code [1] 285543 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 287828 0
Duration of postoperative analgesia:time interval between performing nerve block and the first analgesia request
Timepoint [1] 287828 0
1, 3, 6, 12, and 24 h
Primary outcome [2] 287829 0
and proportion of patients requiring analgesic supplementation for the first 24h
Timepoint [2] 287829 0
24 hours
Secondary outcome [1] 298899 0
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.
Timepoint [1] 298899 0
hourly for 24 hours
Secondary outcome [2] 298953 0
Duration of motor block was defined as the time from LA injection to score 5 of Bromage modified scale of each nerve.
Timepoint [2] 298953 0
hourly for 24 hours

Eligibility
Key inclusion criteria
patients undergoing upper limb wrist/hand/elbow or distal arm surgery
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2012
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
17/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4509 0
Tunisia
State/province [1] 4509 0
tunis

Funding & Sponsors
Funding source category [1] 285878 0
Hospital
Name [1] 285878 0
Tunisian Military Hospital
Country [1] 285878 0
Tunisia
Primary sponsor type
Hospital
Name
Tunisian Military Hospital
Address
20 Montfleury street, 1002, Tunis; Tunisia
Country
Tunisia
Secondary sponsor category [1] 284703 0
None
Name [1] 284703 0
Address [1] 284703 0
Country [1] 284703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287905 0
tunisian military hospital local ethic comittee
Ethics committee address [1] 287905 0
20 Montfleury street, 1002, Tunis; Tunisia
Ethics committee country [1] 287905 0
Tunisia
Date submitted for ethics approval [1] 287905 0
15/08/2012
Approval date [1] 287905 0
25/08/2012
Ethics approval number [1] 287905 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34617 0
A/Prof Trabelsi walid
Address 34617 0
departement of anesthesia and intensive care unit, Tunisian Military Hospital, 20 Montfleury street 1002 Tunis; TUNISIA
Country 34617 0
Tunisia
Phone 34617 0
+21624091983
Fax 34617 0
Email 34617 0
[email protected]
Contact person for public queries
Name 17864 0
trabelsi walid
Address 17864 0
departement of anesthesia and intensive care unit,Tunisian Military Hospital, 20 Montfleury street ,1002 Tunis; Tunisia
Country 17864 0
Tunisia
Phone 17864 0
+216 2409193
Fax 17864 0
Email 17864 0
[email protected]
Contact person for scientific queries
Name 8792 0
trabelsi walid
Address 8792 0
departement of anesthesia and intensive care unit,Tunisian Military Hospital, 20 Montfleury street ,1002 Tunis; Tunisia
Country 8792 0
Tunisia
Phone 8792 0
+2162409193
Fax 8792 0
Email 8792 0
[email protected]

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.