Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001189314p
Ethics application status
Not yet submitted
Date submitted
7/08/2017
Date registered
14/08/2017
Date last updated
14/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Suprascapular block with infraclavicular block in shoulder surgery
Scientific title
Suprascapular block with infraclavicular block as an alternative to interscalene block for analgesia in shoulder surgery
Secondary ID [1] 292609 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pathology 304288 0
pain 304290 0
Condition category
Condition code
Anaesthesiology 303636 303636 0 0
Pain management
Surgery 303637 303637 0 0
Other surgery
Musculoskeletal 303686 303686 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined suprascapular and infraclavicular regional block

Written informed consent obtained. Patients will be randomized to one of the two groups (Group I or Group C). Blocks and anaesthesia will be performed prior to commencement of shoulder surgery when the surgeon is not in the room.

All patients will receive pre medication with 1.5g of oral paracetamol (1g if <50kg), then enter theatre and be positioned on shoulder table. Standard anaesthetic monitoring will be attached (non invasive blood pressure (NIBP), electrocardiography (ECG), pulse oximetry). IV access will be obtained in the contralateral upper limb.
50mcg fentanyl administered IV along with TIVA (Marsh model) target plasma concentration 0.5-1mcg/ml. Intra operative tramadol will be avoided.
Head turned to contralateral side.
Chlorhexidine/alcohol skin prep from mastoid to acromion, nipple and midline anteriorly, and above spine of scapula posteriorly (skin prep will be the same in both groups to maintain surgeon blinding).
Ultrasound guidance used to identify interscalene landmarks (C5/6 roots, anterior and middle scalene muscles).

Group I:
Place interscalene catheter under ultrasound guidance (high frequence linear probe) out of plane with 51mm eCath. Catheter tip aimed beside the C5/6 root, adjacent to middle scalene. Inject 20ml Ropivacaine 0.375%. Readjust needle tip as required to obtain adequate spread of LA. Secure catheter with Friar’s balsam, tegaderm dressing and medipore tape.
Induction of general anaesthesia and positioning for surgery (see details below).
Make small skin punctures with 18G needle as for infraclavicular and suprascapular block.
At end of procedure operating surgeon infiltrates up to 20ml 0.25% plain bupivacaine around the port sites.



Group C:
Place interscalene catheter as above using 20ml NaCl 0.9% instead of ropivicaine and position catheter tip as above to obtain adequate spread. Secure catheter with Friar’s balsam, tegaderm dressing and medipore tape.
Induction of general anaesthesia (see details below).
Site infraclavicular block with 100mm 18G sonoplex needle. In plane approach. Aim to position tip inferior to subclavian artery. Inject 15ml 0.375% ropivacaine to surround subclavian artery.
Position patient in semi sitting position and scan suprascapular fossa. Place needle tip on floor of suprascapular fossa beside suprascapular artery. Inject 10ml 0.375% Ropivacaine just above floor of suprascapular fossa.
At end of procedure operating surgeon infiltrates up to 20ml 0.25% plain marcain around the port sites.


General Anaesthesia Induction:
100% Oxygen via facemask. Increase TCI Propofol to adequate level as judged by anaesthetist and depth of anaesthesia monitoring. (usually 3-6mcg/ml). Commence Remifentanil infusion (TCI Minto effect site concentration 2ng/ml)
Insert supraglottic airway device. PCV with PEEP 5cm H20 to obtain tidal volume of 6ml/kg and ETCO2 40-50mmHg.
Use phenylephrine as required to maintain MAP > 80% of baseline on the ward.
Use glycopyrrolate/atropine as required to maintain HR > 40
Parecoxib 40mg IV given to all patients prior to skin incision.
Additional monitoring – temperature (nasopharyngeal) and Bispectral Index(BIS)/Entropy to maintain < 60.
Intervention code [1] 298822 0
Treatment: Drugs
Comparator / control treatment
Interscalene regional block

Please see description of Group C in "Description of intervention" field in ANZCTR registration form.
Control group
Active

Outcomes
Primary outcome [1] 302992 0
change in lung function measured using Micro Medical Micro Lab Spirometer (FVC and FEV1)
Timepoint [1] 302992 0
comparison from pre-operatively and prior to discharge from PACU
Primary outcome [2] 302993 0
a comparison of the maximum visual analogue pain scores in PACU
Timepoint [2] 302993 0
maximum VAS score while in PACU, measured once post operatively at approximately 1-2 hours
Secondary outcome [1] 337649 0
complication rates - presence or absence of symptomatic haematoma, pneumothorax, persistence of block effect (all assessed clinically by examination)
Timepoint [1] 337649 0
within 24 hrs-2 wks
Secondary outcome [2] 337786 0
patient satisfaction at 24hrs post operatively (using a 2 question survey conducted via a phone call)
Timepoint [2] 337786 0
24hrs post operatively
Secondary outcome [3] 337789 0
opioid use in PACU (in mg as recored in post operative medication charts)
Timepoint [3] 337789 0
1-2 hours post operatively
Secondary outcome [4] 337790 0
block failure as assessed clinically by anaesthetist - insufficient pain relief with absence of sensory or motor block
Timepoint [4] 337790 0
1-2 hours post operatively

Eligibility
Key inclusion criteria
age >=18 years up to 70 years; ASA physical status 1-3 , all patients will be scheduled for arthroscopic shoulder surgery by Ilia Elkinson
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known pulmonary disease except well controlled asthma; diaphragmatic dysfunction or phrenic nerve palsy; allergy to local anaesthetics or other drugs used in study protocol; pre-existing neuropathy; pre-existing coagulopathy; any chronic pain syndrome or chronic opioid use (including regular tramadol use); patients undergoing bone graft harvesting from another body site; recreational drug users; BMI greater than 35

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)
envelope and blinding to all but the anaesthetist administering the block
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using envelopes with 50/50 each group allocation being picked from a box on day of surgery
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
Non inferiority analysis for pain relief
Superiority analysis for lung function

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2017
Actual
Date of last participant enrolment
Anticipated
1/02/2018
Actual
Date of last data collection
Anticipated
12/02/2018
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 9131 0
New Zealand
State/province [1] 9131 0
Wellington

Funding & Sponsors
Funding source category [1] 297196 0
Hospital
Name [1] 297196 0
Capital and Coast District Health Board
Country [1] 297196 0
New Zealand
Primary sponsor type
Hospital
Name
Wellington Regional Hospital
Address
Riddiford St
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 296203 0
None
Name [1] 296203 0
Address [1] 296203 0
Country [1] 296203 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298352 0
HDEC New Zealand
Ethics committee address [1] 298352 0
Ethics committee country [1] 298352 0
New Zealand
Date submitted for ethics approval [1] 298352 0
14/08/2017
Approval date [1] 298352 0
Ethics approval number [1] 298352 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76810 0
Mr Ilia Elkinson
Address 76810 0
Wellington Regional Hospital
Riddiford St
Newtown
Wellington 6021
Country 76810 0
New Zealand
Phone 76810 0
+64 4 385 5999
Fax 76810 0
Email 76810 0
[email protected]
Contact person for public queries
Name 76811 0
Elizabeth Bond
Address 76811 0
Wellington Regional Hospital
Riddiford St
Newtown
Wellington 6021
Country 76811 0
New Zealand
Phone 76811 0
+64 4 385 5999
Fax 76811 0
Email 76811 0
[email protected]
Contact person for scientific queries
Name 76812 0
Elizabeth Bond
Address 76812 0
Wellington Regional Hospital
Riddiford St
Newtown
Wellington 6021
Country 76812 0
New Zealand
Phone 76812 0
+64 4 385 5999
Fax 76812 0
Email 76812 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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