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Trial registered on ANZCTR


Registration number
ACTRN12622001356752
Ethics application status
Approved
Date submitted
15/10/2022
Date registered
21/10/2022
Date last updated
28/07/2024
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of ultrasound-guided supraclavicular block for closed reduction of upper extremity injuries in the emergency department
Scientific title
Ultrasound-guided supraclavicular block versus Bier block for closed reduction of upper extremity injuries in the emergency department: an open-label, non-inferiority, randomised control trial
Secondary ID [1] 308196 0
None
Universal Trial Number (UTN)
Trial acronym
SUPERB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb fracture/dislocation 327941 0
Condition category
Condition code
Emergency medicine 325007 325007 0 0
Other emergency care
Anaesthesiology 325042 325042 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided supraclavicular block (UGSCB): For UGSCB, the patient will be in a semi-reclined sitting position, with their head turned away from the side to be blocked. Patients will be monitored with continuous pulse oximetry, five minutely blood pressure on the unaffected limb and 3 lead ECG. Aseptic technique will be adhered to including sterile gloves, ultrasound probe cover and sterile gel. Following informed written consent, the skin overlying the supraclavicular region will be prepared with chlorhexidine skin preparation and draped. A Sonosite X-Porte ultrasound (Fujifilm) with a 12 MHz linear probe or equivalent will be placed over the supraclavicular fossa to identify the brachial plexus, and its relation to the subclavian artery, pleural and first rib. Colour Doppler will be routinely used to identify and avoid blood vessels. A 22 G echogenic needle (Sonoplex, Pajunk) attached to a 20 ml syringe will be inserted under ultrasound guidance to deposit 10 mls of 0.75% ropivacaine at each of the two sites: 1) at the lower trunk, and 2) between the upper and middle trunks of the brachial plexus. Adequacy of regional block will be assessed by the treating clinician prior to closed reduction of the injured part. Adverse effects including neuropathy, injury to vascular structures, pneumothorax, phrenic nerve palsy, and local anaesthetic toxicity will be recorded.

UGSCB will be performed by an emergency physician competent in this procedure. Currently we have 2 emergency physicians in our department who are competent in performing UGSCB. We intend to conduct a training session prior to data collection for interested clinicians in our department. This will include a 60 minute training session run by a senior anaesthetist with expertise in regional anaesthesia, and closer supervision of the first 5 supraclavicular blocks. The primary outcome is the intensity of pain during closed reduction of the injured part.

The procedure will be performed on patients that require emergency closed reduction of the fracture or dislocation at the time of their presentation to the emergency department. This allows for re-alignment of the injured part such that the patient can be safely discharged home for orthopaedic review in 1-2 weeks time. Upon this review, the orthopaedic team will decide on conservative vs surgical management. Any patients requiring immediate surgical intervention at the time of emergency department presentation will be excluded from the study.
Intervention code [1] 324649 0
Treatment: Other
Comparator / control treatment
Bier block (BB): the patient will be positioned in semi-reclined sitting. Monitoring will include continuous pulse oximetry, five minute interval blood pressure on the unaffected limb and 3 lead ECG. Following informed consent, an intravenous cannula (IVC) will be inserted at or below the antecubital fossa on the injured limb, and a second IVC will be available on the unaffected limb. The BB cuff (AT4, AneticAid, West Yorkshire, United Kingdom) will be applied at the proximal upper limb. The arm then is elevated for 5 minutes to enhance venous drainage, before the cuff is inflated to 100 mmHg above the patient’s systolic blood pressure (to a maximum of 300 mmHg). The radial pulse should not be palpable which provides additional confirmation of adequate cuff pressure. Prilocaine (0.5%, 5 mg/kg to maximum of 50 mg) will be injected via IVC on the affected side. Adequacy of the block is assessed by the treating clinician prior to closed reduction of the injured part. After completion of the closed reduction procedure, the BB cuff should remain inflated until 30 minutes after initial inflation, after which time the cuff can be deflated. Adverse effects including cuff pain/discomfort, localised bruising and systemic local anaesthetic toxicity will be recorded.

BB will be performed by an emergency physician. As BB is the current standard of care and is routinely performed in our department, all emergency physicians are competent and familiar with its use.

Similar to UGSCB, BB will be performed on patients that require emergency closed reduction of the fracture or dislocation at the time of their presentation to the emergency department. This allows for re-alignment of the injured part such that the patient can be safely discharged home for orthopaedic review in 1-2 weeks time. Upon this review, the orthopaedic team will decide on conservative vs surgical management. Any patients requiring immediate surgical intervention at the time of emergency department presentation will be excluded from the study.
Control group
Active

Outcomes
Primary outcome [1] 332821 0
Maximal pain experienced during the closed reduction of the injured part, as reported by the patient on a 10 cm Visual Analogue Scale (VAS) immediately after completion of the procedure, will be the primary outcome measure. The patient will be asked by the treating clinician, nurse or research assistant to mark their pain on a VAS scale printed on paper anchored with “no pain” at 0 cm and “pain as bad as it could possibly be” at 10 cm
Timepoint [1] 332821 0
Immediately after completion of closed reduction of the injured part.
Secondary outcome [1] 414790 0
Patient reported pain: VAS pain scores will also be collected at baseline and maximal pain experienced during UGSCB or BB. The baseline pain score will occur immediately prior to the commencement of the block, then within 5 minutes after the block has been performed but prior to the start of closed reduction procedure. Analgesia administered prior to the procedure will be compared between groups to ensure that they are similar.
Timepoint [1] 414790 0
Prior to commencement of UGSCB or BB, and 5 minutes after completion of the block
Secondary outcome [2] 414791 0
Patient satisfaction: Prior to discharge, the patient will be asked to rate their satisfaction on a 10 cm VAS satisfaction scale anchored with “extremely dissatisfied” at 0 cm and “extremely satisfied” at 10 cm
Timepoint [2] 414791 0
Prior to discharge from the emergency department
Secondary outcome [3] 414792 0
ED length of stay: The time from triage to discharge from ED is recorded automatically in ieMR (integrated electronic medical records). This is the ED legnth of stay and will be obtained on patient discharge.
Timepoint [3] 414792 0
At time of discharge from the emergency department
Secondary outcome [4] 414793 0
Opioid use: Total opioid use including those given by the ambulance service pre-hospital and those given in the ED will be recorded. Total opioid use will be converted to oral morphine milligram equivalent using Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine opioid calculator (http://www.opioidcalculator.com.au/). This will be obtaind from the patient's electronic records through ieMR and, if applicable, the ambulance notes, which are available in the patient's electronic records.
Timepoint [4] 414793 0
At time of discharge from the emergency department
Secondary outcome [5] 414794 0
Procedural time: Total time taken for the intervention will be recorded. For UGSCB, this will start at the time of skin preparation of the patient until completion of closed reduction and immobilisation with plaster of paris of the injured part. For BB, this will start at the time of cuff application to cuff deflation. These times will be recorded by recording the time on the clock at the beginning and completion of the procedure, and recorded on the data collection sheet by the reseacher or treating clinician.
Timepoint [5] 414794 0
At time of patient discharge from the emergency department
Secondary outcome [6] 414893 0
Adverse outcomes: any adverse events experienced by the patient or noted by the treating clinician will be recorded in the data collection sheet and also in the patient's electronic records. These will be prospectively collected for reporting in the final study report.
Timepoint [6] 414893 0
At time of discharge from the emergency department
Secondary outcome [7] 420287 0
Pain intensity on a VAS after discharge from ED.
Timepoint [7] 420287 0
Once between 24-72 hours post-discharge from ED
Secondary outcome [8] 420288 0
Patient satisfaction on a VAS after discharge from ED.
Timepoint [8] 420288 0
Once between 24-72 hours post-discharge from ED
Secondary outcome [9] 420289 0
Adverse effects experienced by the participant after discharge from the ED. These will be self-reported using a questionnairre with the question "Were there any adverse events that you would like to report? If yes, please provide details below." A paper version of the questionnaire will be given to the patient on discharge with reminder to fill out in 24-72 hours post-discharge. In addition, we will also email them an electronic version of the questionnaire to fill out and email back to us.

Examples of adverse events include bruising/haematoma, signs of infection at the injection/IVC sites (such as erythema, warmth, pain) and ongoing parasthesia or weakness.
Timepoint [9] 420289 0
Once between 24-72 hours post-discharge

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion in the study if they are aged 18 years or above, can provide informed consent, and present to the ED with an upper limb fracture and/or dislocation that requires urgent closed reduction and immobilisation in the ED. Injuries that require closed reduction either as definitive management or as interim management prior to surgical intervention, and are amenable to both BB and UGSCB will be included. These include radius and/or ulnar fractures and/or dislocations, elbow fractures and/or dislocations, and distal humerus fractures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded for the following reasons: local anaesthetic allergy, open fractures, unstable fracture or dislocations that require urgent surgical fixation, pregnancy or anticoagulation. Specific contraindications to UGSCB include chronic lung disease (e.g. COPD or unstable asthma), skin infection over the supraclavicular site of injection and previous surgery or radiation therapy to the supraclavicular region. Specific contraindications to BB include severe hypertension, compartment syndrome, congenital or idiopathic methaemoglobinaemia, sickle cell disease, peripheral vascular disease, peripheral neuropathy, cardiac conduction abnormality and upper limb infection (Kendall et al., 1997). As patients may be randomised to either UGSCB or BB, they should not have any contraindications to UGSCB and BB. Patients who are screened and excluded will be noted.

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)
Centralised randomisation will be performed using the Griffith Randomisation Service (https://randomisation.griffith.edu.au/) to either UGSCB or BB.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be performed in 1:1 ratio in random blocks of size 4-6 (size randomly selected) to ensure equal numbers in each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-inferiority randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be summarised as mean (standard deviation) or median (interquartile range) for continuous variables, depending on the normality of their distribution, and as frequency (percentage) for categorical variables. The primary outcome of maximal pain during the procedure will be assessed as a non-inferiority hypothesis using data from the 10 cm VAS tool. The between-group difference in maximal pain will be assessed using linear regression modelling with group allocation (UGSCB vs BB) included as a main effect. A conclusion of non-inferiority will be determined if the 95% confidence interval for the between-group difference in mean maximal pain is entirely above the non-inferiority margin. Analysis will be performed on an intention-to-treat basis, with results of a secondary per-protocol analysis also reported.

Analysis of secondary outcomes will include patient satisfaction, opioid use, procedure time, ED length of stay, adverse events and intervention failure. Linear regression modelling will be used to compare continuous outcome data, including between-group difference in patient satisfaction on the 10 cm VAS satisfaction scale and total opiate dose in mg of morphine equivalent. Difference in median procedural time and ED length of stay will be compared using median regression. Odds of dichotomous outcomes will be compared using logistic regression modelling. Formal adjustment for multiplicity will not be performed. Missing data will be reported but not imputed. Analysis will be performed on Stata (StataCorp), v14.2 or later.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/03/2023
Actual
5/04/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
8/06/2024
Date of last data collection
Anticipated
30/06/2024
Actual
12/07/2024
Sample size
Target
76
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23375 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 38760 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 312452 0
Hospital
Name [1] 312452 0
Metro South Health
Country [1] 312452 0
Australia
Funding source category [2] 313738 0
Charities/Societies/Foundations
Name [2] 313738 0
Emergency Medicine Foundation
Country [2] 313738 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health
Address
Metro South Research, Metro South Health
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 314030 0
None
Name [1] 314030 0
Address [1] 314030 0
Country [1] 314030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311797 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 311797 0
Ethics committee country [1] 311797 0
Australia
Date submitted for ethics approval [1] 311797 0
15/10/2022
Approval date [1] 311797 0
21/12/2022
Ethics approval number [1] 311797 0
HREC/2022/QMS/89716

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

Contacts
Principal investigator
Name 122402 0
Dr Henry Tsao
Address 122402 0
Redland Hospital
Weippin Street
Cleveland QLD 4163
Country 122402 0
Australia
Phone 122402 0
+61 402054279
Fax 122402 0
Email 122402 0
henry.tsao@health.qld.gov.au
Contact person for public queries
Name 122403 0
Henry Tsao
Address 122403 0
Redland Hospital
Weippin Street
Cleveland QLD 4163
Country 122403 0
Australia
Phone 122403 0
+61 402054279
Fax 122403 0
Email 122403 0
henry.tsao@health.qld.gov.au
Contact person for scientific queries
Name 122404 0
Henry Tsao
Address 122404 0
Redland Hospital
Weippin Street
Cleveland QLD 4163
Country 122404 0
Australia
Phone 122404 0
+61 402054279
Fax 122404 0
Email 122404 0
henry.tsao@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, may be shared upon reasonable request.
When will data be available (start and end dates)?
Immediately after publication and ending at 15 years following main results publication, as recommended by the NHMRC.
Available to whom?
The data can be made available to researchers upon reasonable request and this will be on a case-by-case basis at discretion
Available for what types of analyses?
The data will be available for any research with methdologically sound proposal
How or where can data be obtained?
Access to the data will be subject to approval by the principal investigator and Metro South Research. Please contact the principal investigator on henry.tsao@health.qld.gov.au or Metro South Health Research on msh-research@health.qld.gov.au.


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
SourceTitleYear of PublicationDOI
EmbaseUltrasound-guided supraclavicular block versus Bier block for emergency reduction of upper limb injuries: a protocol for an open-label, non-inferiority, randomised controlled trial.2023https://dx.doi.org/10.1186/s13063-023-07403-z
N.B. These documents automatically identified may not have been verified by the study sponsor.