Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000298617
Ethics application status
Approved
Date submitted
11/03/2014
Date registered
20/03/2014
Date last updated
20/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
effect of catheter tip location on the efficacy of ultrasound guided interscalene brachial plexus block.
Scientific title
quality of analgesia after two different location of catheter tip during ultrasound guided continuous interscalene brachial plexus block in patients underwent shoulder surgery.
Secondary ID [1] 284212 0
nil
Universal Trial Number (UTN)
U1111-1154-1489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
analgesia following shoulder surgery 291318 0
Condition category
Condition code
Anaesthesiology 291672 291672 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
group 1: interscalene catheter was placed between the fifth and the sixth cervical roots (C5-C6) ; 20 minutes before general anaesthesia.
(which was the same in the two groupes)
Intervention code [1] 288910 0
Treatment: Devices
Comparator / control treatment
group 2: interscalene catheter was placed between the sixth and the seventh cervical roots (C6-C7) ; 20 minutes before general anaesthesia.
((which was the same in the two groupes)
Control group
Active

Outcomes
Primary outcome [1] 291614 0
quality of analgesia assessed by visual analogic scale at rest
Timepoint [1] 291614 0
regular intervals: 0 (at extubation),1, 3,12, 24 and 48h post operatively
Primary outcome [2] 291615 0
quality of analgesia assessed by Visual analogic scale at mouvement (arm abduction)
Timepoint [2] 291615 0
regular intervals 12, 24 and 48 h post operatively
Secondary outcome [1] 307162 0
Duration of the insertion procedure of interscalene catheter
Timepoint [1] 307162 0
from the beginning of the puncture until catheter fixation

Eligibility
Key inclusion criteria
Patients requiring continuous interscalene analgesia following elective shoulder surgery (Latarjet technique)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient refusal .
- Severe respiratory disease.
- Known neuropathy involving the arm undergoing surgery.
- Known allergy to local anaesthetic drugs.
- Chronic opioid therapy.
- Infection at site of needle puncture

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)
Subjects will be recruited by anesthesiologist in pre-anesthetic consultation prior to surgery (with informed consent).
Allocation of treatment by randomised number generator will be used to assign the patient to one of the 2 groups.

sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/03/2014
Actual
Date of last participant enrolment
Anticipated
16/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5887 0
Tunisia
State/province [1] 5887 0
tunis

Funding & Sponsors
Funding source category [1] 288871 0
Hospital
Name [1] 288871 0
Tunisian Military Hospital
Country [1] 288871 0
Tunisia
Primary sponsor type
Hospital
Name
Tunisian Military Hospital
Address
20 Montfleury street, 1002 Tunis; Tunisia
Country
Tunisia
Secondary sponsor category [1] 287565 0
None
Name [1] 287565 0
Address [1] 287565 0
Country [1] 287565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290698 0
Tunisian Military Hospital local ethics comittee
Ethics committee address [1] 290698 0
20 Montfleury street 1002 Tunis
Ethics committee country [1] 290698 0
Tunisia
Date submitted for ethics approval [1] 290698 0
04/02/2014
Approval date [1] 290698 0
25/02/2014
Ethics approval number [1] 290698 0

Summary
Brief summary
The purpose of this study is to compare 2 different places of the tip of ultrasound guided interscalene brachial plexus catheter for analgesia in patients having elective shoulder surgery. We plan to assess the effectiveness of analgesia, side effects and patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46738 0
A/Prof Trabelsi walid
Address 46738 0
department of anesthesia and intensive care unit, Tunisian Military Hospital; 20 Montfleury street, 1002,Tunis; Tunisia
Country 46738 0
Tunisia
Phone 46738 0
+21624091983
Fax 46738 0
Email 46738 0
[email protected]
Contact person for public queries
Name 46739 0
A/Prof Trabelsi walid
Address 46739 0
department of anesthesia and intensive care unit, Tunisian Military Hospital; 20 Montfleury street, 1002,Tunis; Tunisia
Country 46739 0
Tunisia
Phone 46739 0
+21624091983
Fax 46739 0
Email 46739 0
[email protected]
Contact person for scientific queries
Name 46740 0
A/Prof Trabelsi walid
Address 46740 0
department of anesthesia and intensive care unit, Tunisian Military Hospital; 20 Montfleury street, 1002,Tunis; Tunisia
Country 46740 0
Tunisia
Phone 46740 0
+21624091983
Fax 46740 0
Email 46740 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
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