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Trial registered on ANZCTR


Registration number
ACTRN12608000481370
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
29/09/2008
Date last updated
11/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of ultrasound and nerve stimulation for interscalene catheter placement
Scientific title
Ultrasound and nerve stimulation as methods for interscalene catheter placement for shoulder surgery: Effect on analgesia
Secondary ID [1] 259927 0
USNS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following shoulder surgery 3519 0
Condition category
Condition code
Anaesthesiology 3673 3673 0 0
Other anaesthesiology
Anaesthesiology 3720 3720 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interscalene catheter placed using either ultrasound or nerve stimulation


Ultrasound (US) Group
The needle will be advanced superficially in a caudal and peripheral direction until tissue displacement is observed just lateral to the brachial plexus trunks in the body of the middle scalene muscle. 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 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. Sustained muscle twitches at 0.2-0.5mA will not be sought. If satisfactory US images cannot be attained within 5 min, the probe will be discarded and interscalene catheter (ISC) placement conducted blind as per the NS group.
Duration of procedure: 15 min
Intervention code [1] 3236 0
Treatment: Devices
Comparator / control treatment
Neurostimulation method

Nerve Stimulation (NS) Group
The needle will be advanced superficially in a caudal and peripheral direction until a deltoid, pectoralis major, biceps or triceps muscle twitch is elicited at current of 0.2-0.5 mA (pulse width 0.1 ms). Dextrose 5% 5-10 mL will then be injected down the needle and a non-stimulating catheter advanced 2 cm past the needle tip.
Duration of procedure: 15 min
Control group
Active

Outcomes
Primary outcome [1] 4578 0
Analgesic consumption and pain scores during first 48 hours, researcher questioning patient on days 1 and 2.
Assessment tool: numerical rating pain score (0-10).
Timepoint [1] 4578 0
During first 48 hours after the procedure is completed, researcher questioning patient in the afternoon of days 1 and 2.
Secondary outcome [1] 7736 0
Needle time under the skin at interscalene catheter (ISC) insertion.
Timepoint [1] 7736 0
At time of ISC insertion.

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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent, age no limits
2. Allergy amide local anaesthetic (LA) drugs
3. Existing neurological disorders/neuropathy of the operative extremity
4. Infection at site of needle puncture
5. Ischaemic heart disease
6. Chronic opioid therapy

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 phone call during the week prior to surgery
4. By Participant Information Sheet mailed during the week prior to surgery

Allocation of treatment by randomised number generator 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1101 0
New Zealand
State/province [1] 1101 0
Auckland

Funding & Sponsors
Funding source category [1] 3699 0
Hospital
Name [1] 3699 0
Anaesthesia Research Trust
Address [1] 3699 0
Auckland City Hospital
Park Road
Grafton
Auckland 11023
Country [1] 3699 0
New Zealand
Funding source category [2] 4353 0
Commercial sector/Industry
Name [2] 4353 0
I-Flow Corporation
Address [2] 4353 0
Lake Forrest Drive, Lake Forrest, CA 92630
Country [2] 4353 0
United States of America
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] 3317 0
None
Name [1] 3317 0
Address [1] 3317 0
Country [1] 3317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5749 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5749 0
P O Box 1031
Hamilton 3240
Waikato
Ethics committee country [1] 5749 0
New Zealand
Date submitted for ethics approval [1] 5749 0
Approval date [1] 5749 0
31/03/2008
Ethics approval number [1] 5749 0
NTY/07/09/103

Summary
Brief summary
The purpose of this current study is to compare two methods of interscalene brachial plexus catheter placement in patients having elective shoulder surgery. We plan to assess indices of both catheter effectiveness and technical ease of catheter insertion.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 28817 0
Dr Michael Fredrickson
Address 28817 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 28817 0
New Zealand
Phone 28817 0
+619522 1117
Fax 28817 0
Email 28817 0
anaesthesiainstitute@yahoo.com
Contact person for public queries
Name 11974 0
Dr Dr Michael Fredrickson
Address 11974 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11974 0
New Zealand
Phone 11974 0
0064 9 522 1117
Fax 11974 0
0064 9 522 1127
Email 11974 0
anaesthesiainstitute@yahoo.com
Contact person for scientific queries
Name 2902 0
Dr Dr Michael Fredrickson
Address 2902 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 2902 0
New Zealand
Phone 2902 0
0064 9 522 1117
Fax 2902 0
0064 9 522 1127
Email 2902 0
anaesthesiainstitute@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary