Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000768291
Ethics application status
Approved
Date submitted
25/08/2009
Date registered
4/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of anterior and posterior approaches for ultrasound guided interscalene catheter placement
Scientific title
Ultrasound guided interscalene catheter placement in patients undergoing elective shoulder surgery: a comparison of anterior vs posterior approaches
Secondary ID [1] 253570 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following shoulder surgery 243536 0
Condition category
Condition code
Anaesthesiology 239836 239836 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Posterior Group
The needle will be inserted at a point posteriorly and advanced anteriorly in the plane of the ultrasound (US) beam until the needle tip is visualised just lateral to the 2 most superficial elements of the brachial plexus.
In both groups, dextrose 5% 5-10 mL will be injected down the needle to observe for appropriate fluid spread adjacent to the brachial plexus trunks, and a non-stimulating catheter advanced 1-2 cm past the needle tip. If US imaging proves difficult, a brief appropriate muscle twitch will be sought with a nerve stimulator set to 0.8 mA to confirm brachial plexus position.
Intervention code [1] 241145 0
Treatment: Devices
Comparator / control treatment
Anterior Group

The needle will be inserted at a point approximately 3 cm cephalad to the level of sixth cervical vertebra (C6) at the posterior border of sternomastoid muscle. The bevel of the needle will be orientated laterally throughout. A 10-5 MHz linear US probe (Sonosite L38, Bothell, WA) will then be placed in the axial plane at the level of C6 (Sonosite Micromaxx, Bothell, WA). The needle will be advanced superficially in a caudal and peripheral direction until tissue displacement is observed just lateral to the 2 most superficial elements of the brachial plexus.

Skin preparation and interscalene catheter (ISC) dressing management will be the same as for the 'posterior' group.
Control group
Active

Outcomes
Primary outcome [1] 240601 0
Primary outcome endpoint to be assessed is postoperative pain during the first 24 hours after surgery as assesssed by blinded research assistant by phone.
Timepoint [1] 240601 0
During the first 24 postoperative hours
Secondary outcome [1] 257234 0
Catheter placement time
Timepoint [1] 257234 0
At the time of catheter insertion by the Principal Investigator (PI), the Anaesthesia Assistant will record time taken for catheter insertion.
Secondary outcome [2] 257326 0
Degree of patient comfort during insertion.
Timepoint [2] 257326 0
At the time of catheter insertion by the Principal Investigator (PI), the Anaesthesia Assistant will record the degree of patient discomfort by Numerical Rating Pain Score (NRPS) 0-10.

Eligibility
Key inclusion criteria
Patients requiring continuous interscalene analgesia following elective shoulder surgery under the care of the Principal Investigator.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal for interscalene block.
2. Severe respiratory disease or ischaemic heart disease.
3. Known neuropathy involving the arm undergoing surgery.
4. Known allergy to amide local anaesthetic drugs.
5. Chronic opioid therapy.
6. 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 from/by:
1. Surgeon in his rooms.
2. By selection from the operation list.
3. By Participant Information Sheet mailed approximately 2 weeks prior to surgery.
4. By phone call during the week prior to surgery.
5. With informed consent in consultation with the PI.
Allocation of treatment by randomised number generator will be used to assign the patient to one of the 2 groups.
Allocation is concealed in 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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1958 0
New Zealand
State/province [1] 1958 0
Auckland

Funding & Sponsors
Funding source category [1] 237514 0
Charities/Societies/Foundations
Name [1] 237514 0
Auckland Medical Research Foundation
Country [1] 237514 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute P O Box 109 199 Newmarket Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 236993 0
None
Name [1] 236993 0
Address [1] 236993 0
Country [1] 236993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243645 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 243645 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 243645 0
New Zealand
Date submitted for ethics approval [1] 243645 0
13/08/2009
Approval date [1] 243645 0
01/09/2009
Ethics approval number [1] 243645 0
NTY/07/09/103

Summary
Brief summary
The purpose of this current study is to compare the 'in-plane' with 'out-of-plane' methods of ultrasound guided interscalene brachial plexus catheter placement for analgesia in patients having elective shoulder surgery. We plan to assess the effectiveness of analgesia, side effects and patient satisfaction. There is controversy surrounding the best approach for placing these catheters, hence the reasons for doing the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30065 0
Address 30065 0
Country 30065 0
Phone 30065 0
Fax 30065 0
Email 30065 0
Contact person for public queries
Name 13312 0
Dr Michael Fredrickson
Address 13312 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 13312 0
New Zealand
Phone 13312 0
+64 9 522 1117
Fax 13312 0
+64 9 522 1127
Email 13312 0
aiservice@xtra.co.nz
Contact person for scientific queries
Name 4240 0
Dr Michael Fredrickson
Address 4240 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 4240 0
New Zealand
Phone 4240 0
+64 9 522 1117
Fax 4240 0
+64 9 522 1127
Email 4240 0
aiservice@xtra.co.nz

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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