Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001147572
Ethics application status
Approved
Date submitted
1/05/2009
Date registered
28/10/2015
Date last updated
28/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of combined suprascapular and axillary (circumflex) nerve block with interscalene block for providing pain relief following shoulder surgery
Scientific title
A randomised comparison of combined suprascapular and axillary (circumflex) nerve block with interscalene block for postoperative analgesia following arthroscopic shoulder surgery
Secondary ID [1] 287605 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain folowing arthroscopic shoulder surgery 4704 0
Condition category
Condition code
Anaesthesiology 5020 5020 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined suprascapular and axillary (circumflex) nerve block
Ropivacaine 0.75 % 30ml total. 15ml applied to each nerve via 10cm 22 guage insulated needle using a nerve stimulator set between 1.0 and 0.5 milliamps.
Expected duration of nerve block is 12 to 18 hours
Intervention code [1] 4467 0
Treatment: Drugs
Comparator / control treatment
Interscalene brachial plexus nerve block
Ropivacaine 0.75 % 30ml applied to brachial plexus of nerves via 5cm 22 guage insulated needle using a nerve stimulator set between 1.0 and 0.5 milliamps.
Expected duration of nerve block is 12 to 18 hours
Control group
Active

Outcomes
Primary outcome [1] 5906 0
Postoperative pain scores. A numerical rating scale from 0 to 10 will be used and the patients with the patients verbal response recorded. Ten is the maximal score ('the worst pain you could imagine'), while a score of zero is indicates no pain. The patients requirement for postoperttive intravenous and oral morphine will also be recorded at each time interval.
Timepoint [1] 5906 0
Following initial emergence in recovery, then at 2 hours, 6 hours and 24hours postoperatively
Secondary outcome [1] 241955 0
Side effects and complications. These include complications upon injection ie inadvertaent injection into nerves, arteries, veins, the pleura, the epidural space or the cerebrospinal fluid. These will be recorded by the proceduralist.

Side effects include a sensation of difficulty breathing (diaphragm paralysis), droopy eye (Horner's syndrome), hoarseness, and weakness and loss of sensation in the arm and hand.
These will be assessed upon questioning the patient and by assessment following emergence.
Timepoint [1] 241955 0
Following initial emergence in recovery, then at 2 hours, 6 hours and 24 hours postoperatively

Eligibility
Key inclusion criteria
Patients requiring minor arthroscopic shoulder surgery under the care of the principal investigators and coninvestigators.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Communication problems due to deafness or cognitive impairment
Preexisting neurological disease affecting brachial plexus and its terminal nerves on the operative side
Allergy to amide local anaesthetic
Chronic opioid usage
Severe respiratory disease
Intolerance of all non-steroidal anti-inflammatory drugs
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/11/2009
Date of last participant enrolment
Anticipated
Actual
18/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
106
Recruitment outside Australia
Country [1] 1743 0
New Zealand
State/province [1] 1743 0

Funding & Sponsors
Funding source category [1] 4882 0
Other Collaborative groups
Name [1] 4882 0
Australia and New Zealand College of Anaesthetists Novice Reaserch Grant
Country [1] 4882 0
Australia
Primary sponsor type
University
Name
University of Auckland
Address
Victoria St West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 290894 0
None
Name [1] 290894 0
None
Address [1] 290894 0
None
Country [1] 290894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6947 0
Northern Y Ethics Committee
Ethics committee address [1] 6947 0
Northern Y Ethics Committee
Ministry of Health
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
Ethics committee country [1] 6947 0
New Zealand
Date submitted for ethics approval [1] 6947 0
02/04/2009
Approval date [1] 6947 0
28/08/2009
Ethics approval number [1] 6947 0
NTY/09/04/033

Summary
Brief summary
Pain following shoulder surgery can be severe, and can be minimised by the application of local anaesthetic to the nerves supplying the shoulder. This study compares the traditional technique, which involves an injection into the side of the neck, with a new technique that involves two injections around the back of the shoulder.
The aim of the study is determine how the techniques compare with regard to the quality of pain relief, and side effects and complications
Trial website
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 29555 0
Dr Darcy Price
Address 29555 0
Department of Anaesthesia
North Shore Hospital
124 Shakespeare Rd
PO.Box 93-503
Takapuna
Auckland 0622
Country 29555 0
New Zealand
Phone 29555 0
64-9-4861491
Fax 29555 0
Email 29555 0
darcy.price@waitematadhb.govt.nz
Contact person for public queries
Name 12802 0
Dr Darcy Price
Address 12802 0
Department of Anaesthesia
North Shore Hospital
124 Shakespeare Rd
PO.Box 93-503
Takapuna
Auckland 0740
Country 12802 0
New Zealand
Phone 12802 0
64-9-4861491
Fax 12802 0
Email 12802 0
darcy.price@waitematadhb.govt.nz
Contact person for scientific queries
Name 3730 0
Dr Darcy Price
Address 3730 0
Department of Anaesthesia
North Shore Hospital
124 Shakespeare Rd
PO.Box 93-503
Takapuna
Auckland 0740
Country 3730 0
New Zealand
Phone 3730 0
64-9-4861491
Fax 3730 0
Email 3730 0
darcy.price@waitematadhb.govt.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
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Documents added automatically
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