Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000923864
Ethics application status
Approved
Date submitted
25/08/2012
Date registered
30/08/2012
Date last updated
25/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of warmed bupivacaine on the efficacy of ultrasound guided axillary brachial plexus block
Scientific title
Changes in the onset time of the sensory and motor blockade and changes in the duration of analgesia after warming local anesthetic solution during ultrasound guided axillary brachial plexus block in patients underwent upper arm surgery.
Secondary ID [1] 281092 0
nil
Universal Trial Number (UTN)
U1111-1133-8146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
need of adjuncts to local anesthetics in regional anesthesia 287247 0
Condition category
Condition code
Anaesthesiology 287572 287572 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
group H: received 15ml bupivacaine 0.5%.
the solution is stored for more than 24 hours in a freezer cabinet in which the temperature was maintained at 20 degrees C; The syringes and needles used for anesthesia were stored in the same room.

a single shot ultrasound guided axillary block
Intervention code [1] 285544 0
Treatment: Drugs
Comparator / control treatment
group C: the solution used (15 ml of 0.5% bupivacaine) was warmed up to 37 degrees C using a water bath. Bupivacaine ampoules were maintained at a temperature of 37 dgrees C when stored in the water bath for 20 minutes. The syringes and needles used were stored in this water bath for more than two hours, before the start of the procedure.

a single shot ultrasound guided axillary block
Control group
Active

Outcomes
Primary outcome [1] 287833 0
onset time of the sensory blockade: time interval between end of local anesthetic injection and complete sensory blockade in nerve-specific dermatome
Timepoint [1] 287833 0
every five minutes and for 30 minutes. The innervated areas (each dermatome) was evaluated using a pinprick and was rated on a scale from 100% (normal sensation) to 0% (no sensation)
Primary outcome [2] 287834 0
onset time of the motor blockade was defined as score 0 of Bromage modified scale
Timepoint [2] 287834 0
every five minutes and for 30 minutes
Secondary outcome [1] 298900 0
the duration of analgesia: assessedby the first analgesia request
Timepoint [1] 298900 0
regular intervals 1, 3, 6, 12, and 24 h

Eligibility
Key inclusion criteria
The subjects who underwent upper limb surgery from distal arm
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with coagulopathy or neurological disorder

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Completed
Date of first participant enrolment
Anticipated
3/09/2012
Actual
18/09/2012
Date of last participant enrolment
Anticipated
Actual
14/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4510 0
Tunisia
State/province [1] 4510 0

Funding & Sponsors
Funding source category [1] 285879 0
Hospital
Name [1] 285879 0
Tunisian Military Hospital
Country [1] 285879 0
Tunisia
Primary sponsor type
Hospital
Name
Tunisian Military Hospital
Address
20 Montfleury street 1002, Tunis
Country
Tunisia
Secondary sponsor category [1] 284704 0
None
Name [1] 284704 0
Address [1] 284704 0
Country [1] 284704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287906 0
Tunisian Military Hospital local ethics comittee
Ethics committee address [1] 287906 0
Ethics committee country [1] 287906 0
Tunisia
Date submitted for ethics approval [1] 287906 0
Approval date [1] 287906 0
22/08/2012
Ethics approval number [1] 287906 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34618 0
A/Prof Trabelsi walid
Address 34618 0
departement of anesthesia and intensive care unit,Tunisian Military Hospital, 20 Montfleury street ,1002 Tunis; Tunisia
Country 34618 0
Tunisia
Phone 34618 0
+21624091983
Fax 34618 0
Email 34618 0
[email protected]
Contact person for public queries
Name 17865 0
trabelsi walid
Address 17865 0
department of anesthesia and intensive care unit, Tunisian Military Hospital; 20 Montfleury street, 1002,Tunis; Tunisia
Country 17865 0
Tunisia
Phone 17865 0
+21624091983
Fax 17865 0
Email 17865 0
[email protected]
Contact person for scientific queries
Name 8793 0
trabelsi walid
Address 8793 0
department of anesthesia and intensive care unit, Tunisian Military Hospital; 20 Montfleury street, 1002,Tunis; Tunisia
Country 8793 0
Tunisia
Phone 8793 0
+21624091983
Fax 8793 0
Email 8793 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
SourceTitleYear of PublicationDOI
EmbaseEffect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.2017https://dx.doi.org/10.1016/j.otsr.2016.10.010
N.B. These documents automatically identified may not have been verified by the study sponsor.