Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000095460p
Ethics application status
Not yet submitted
Date submitted
24/01/2016
Date registered
29/01/2016
Date last updated
29/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Continouous versus Single-injection Interscalene block for minor Shoulder surgery
Scientific title
Continuous versus Single Shot regional block in shoulder surgery
Secondary ID [1] 288405 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder musculoskeletal pathology
 297415 0
Regional anaesthesia 297416 0
Condition category
Condition code
Anaesthesiology 297601 297601 0 0
Pain management
Musculoskeletal 297603 297603 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To compare two different forms of delivery of regional anaesthesia during shoulder surgery
The continuous block uses 20ml of 0.5% ropivacaine as a bolus through a catheter prior to general anaesthesia, after a surgical duration of average 90 minutes, the block is administered post operatively with continuous infusion of 0.2% ropivacaine at 2 ml/h with patient-controlled bolus of 5 ml hourly for five days post surgery.
The patient press a button on the pump to administer 5ml of ropivacaine when they experience pain, this is in addition to the base rate of 2ml/hr. The patient can not have another 5ml additional bolus until an hour later for safety reason. This is common administration for all currently available regional block pain pump.
The anaesthetist places the block using ultrasound guidance aiming at the region around brachial plexus between the neck and the clavicle. The success of the block is checked with a cold object (e.g ice cube) after patient is awake after surgery.
Intervention code [1] 293718 0
Treatment: Drugs
Comparator / control treatment
The control group will receive a bolus of 20ml of 0.5% ropivacaine through a catheter immediately prior to general anaesthesia followed by continuous infusion of normal saline at 2ml/h with patient-controlled bolus of 5ml saline hourly for five days post surgery. The anaesthetist administers the block with ultraound guidance at the brachial plexus between the neck and the clavicle. Again this is checked with patient's sensation to cold after procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 297145 0
subjective pain score VAS
Timepoint [1] 297145 0
day 7 post surgery
Secondary outcome [1] 320162 0
patient will record the use of pain medications on daily basis
Timepoint [1] 320162 0
first week post surgery
Secondary outcome [2] 320163 0
length of hospital stay via hospital record
Timepoint [2] 320163 0
from end of surgery to discharge from hospital
Secondary outcome [3] 320164 0
the patient will record when they first request the use of pain medication to control pain after surgery
Timepoint [3] 320164 0
between end of the surgery and the first time the patient experience pain and request pain medications after surgery
Secondary outcome [4] 320165 0
total hours of sleep with self reported sleep diary
Timepoint [4] 320165 0
first week post surgery
Secondary outcome [5] 320166 0
complications such as infection at the injection site, hypersthesia at the particular dermatome from the block, or persistent weakness of the particular myotome from the block
The adverse event are assessed by self report of symptoms in pain diary
Timepoint [5] 320166 0
daily assessment of adverse events on diary until 7 days post surgery

Eligibility
Key inclusion criteria
All patients undergoing minor shoulder surgery in wellington catchment area
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwilling to consent – those unwilling to consent to participation in the study cannot be included due to ethical reasons.
2. Major shoulder surgery – those who are undergoing major shoulder surgery with surgical incision of more than five centimetres were excluded such as arthroplasty surgery or open shoulder stabilisation procedures. These were generally more painful with prolonged recovery.
3. Complex regional pain syndrome – those who have existing complex regional pain syndrome or previous hyper sensitivity to pain were likely to have significant difficulties with pain management after surgery.
4. Contraindications to interscalene regional block – those who have absolute contraindications to regional block are excluded, such as severe allergic reaction to local anaesthetic agent or contralateral phrenic nerve dysfunction.
5. Failed regional block – those who have severe pain immediately after surgery with clinical evidence of normal sensation of the intended block region were excluded. Normal sensation indicates the regional block may not been placed around the targeted nerve.

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)
allocation options will be consealed in identical opaque envelops. These will be stored in a secure location and only opened while patient is in theatre preparing to undergo anaesthesia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pre study power analysis was undertaken based on a previous study. We estimated average pain score of 3 and standard deviation of 3 in the continuous block group at day 7. In order to detect a clinical significant pain score difference (>3) with a 90% study power, a minimum of 44 patients are required. We aim to recruit an overall of 50 patients with 25 patients of each study arm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
Date of last participant enrolment
Anticipated
1/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 7549 0
New Zealand
State/province [1] 7549 0
Wellington

Funding & Sponsors
Funding source category [1] 292757 0
Hospital
Name [1] 292757 0
wellington hospital research fund
Country [1] 292757 0
New Zealand
Primary sponsor type
Hospital
Name
wellington hospital orthopaedic department
Address
Riddiford St, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 291487 0
None
Name [1] 291487 0
Address [1] 291487 0
Country [1] 291487 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294242 0
Health and Disability ethics committees
Ethics committee address [1] 294242 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6145
New Zealand
Ethics committee country [1] 294242 0
New Zealand
Date submitted for ethics approval [1] 294242 0
10/02/2016
Approval date [1] 294242 0
Ethics approval number [1] 294242 0

Summary
Brief summary
Minor shoulder surgery is a commonly performed surgical procedure in New Zealand. This includes various forms of mini-open and arthroscopic procedures such as acromial spur removal, rotator cuff repair, excision of distal clavicle, and shoulder stabilisation. Patients undergoing these procedures frequently report pain in the immediate post operative recovery period.
Without proper pain management, complications can occur such as excessive analgesia usage, complex regional pain and delayed rehabilitation. These problems consequently lead to patient’s dissatisfaction and disability, unnecessary hospital admissions, and sometimes further surgery.
The addition of a regional interscalene block to the standard general anaesthesia helps to significantly reduce pain in the first week after rotator cuff surgery. There are two alternative methods of delivery of the regional block. A single shot injection block was performed by the anaesthetist by placing local anaesthetic agent around the interscalene region prior to surgery. Alternatively a continuous block utilises a pump delivering five days of the same local anaesthetic agent to the same region. Both blocks are commonly practiced in New Zealand, however the effectiveness has not been clearly distinguished in all minor shoulder surgery procedures.
This study aim to investigate the difference between these two blocks in terms of patient’s pain management during the first week after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63018 0
Mr Justin Chou
Address 63018 0
Wellington Hospital Orthopaedic Department
Riddiford St, Newtown, Wellington 6021
Country 63018 0
New Zealand
Phone 63018 0
+64 4 385 5999
Fax 63018 0
Email 63018 0
[email protected]
Contact person for public queries
Name 63019 0
Mr Justin Chou
Address 63019 0
Wellington Hospital Orthopaedic Department
Riddiford St, Newtown, Wellington 6021
Country 63019 0
New Zealand
Phone 63019 0
+64 4 385 5999
Fax 63019 0
Email 63019 0
[email protected]
Contact person for scientific queries
Name 63020 0
Mr Justin Chou
Address 63020 0
Wellington Hospital Orthopaedic Department
Riddiford St, Newtown, Wellington 6021
Country 63020 0
New Zealand
Phone 63020 0
+64 4 385 5999
Fax 63020 0
Email 63020 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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