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Trial registered on ANZCTR


Registration number
ACTRN12618000226202
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
12/02/2018
Date last updated
15/09/2020
Date data sharing statement initially provided
26/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Periosteal Block to. Biers Block (Intravenous Regional Anaesthesia) for the reduction of distal radius fractures
Scientific title
Periosteal Block vs. Biers Block (IVRA) for the Reduction of Distal Radius Fractures in Emergency Room patients - a randomised trial of pain control
Secondary ID [1] 293774 0
None
Universal Trial Number (UTN)
U1111-1207-7168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
distal radius fracture 306170 0
Condition category
Condition code
Anaesthesiology 305282 305282 0 0
Pain management
Injuries and Accidents 305394 305394 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single centre, prospective, randomized clinical trial with consecutive recruitment of adult patients (greater than or equal to 16 years) presenting to the Dunedin Emergency Department with a distal radius fracture requiring manipulation.
Study Setting: Single Emergency Department Emergency Department Providers will undergo brief training in Periosteal Block (Arm 1) and IVRA (arm 2) for distal radius fractures. Training will be provided by study investigators. The procedure will be administered by the treating emergency physician.
Arm 1: Periosteal block will be performed by treating ED physicians. The block will be performed with an injection of 15ml of 1% lidocaine
Arm 2:IVRA (aka Biers Block) Performed using 3 ml/kg 0.5% Prilocaine




Intervention code [1] 300028 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304439 0
We will compare of pain score using 100mm visual analogue scale (VAS) during manipulation for patients undergoing periosteal block to those undergoing Intravenous Regional Anaesthesia (IVRA).
Timepoint [1] 304439 0
Immediately following fracture reduction
Secondary outcome [1] 341935 0
(ii) re-manipulation rates of the two techniques assessed by physician self reporting
Timepoint [1] 341935 0
Assessed by questionnaire designed specifically for this study during ED visit
Secondary outcome [2] 341936 0
(iii) provider assessment of ease of performance of the periosteal block compared to IVRA.

Timepoint [2] 341936 0
Assessed by questionnaire designed specifically for this study during ED visit
Secondary outcome [3] 341937 0
iv) emergency department length of stay for the two groups.

Timepoint [3] 341937 0
Assessed by time stamps performed in electronic medical record during ED visit
Secondary outcome [4] 341938 0
(v) comparison of adequate reduction rates for the two groups, Assessed by retrospective physician review of radiology imaging performed during initial ED visit
Timepoint [4] 341938 0
within 1 month after ED visit

Eligibility
Key inclusion criteria
Patients 16 years or older with a distal radius fracture undergoing closed reduction in the Emergency Department are eligible. This will include fractures where closed reduction is performed as definitive management and cases in which reduction is performed in the ED prior to definitive operative reduction and fixation.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: Open fractures, patients unable to provide consent, evidence of compartment syndrome, lignocaine or local anaesthetic allergy, history of sickle cell disease or Raynauds, patients with severe distracting injury, severe peripheral vascular disease, systolic BP >200, severe hepatic failure, or need for bilateral manipulation.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Pain will be measured using a 100-mm visual analogue scale (VAS). We estimated 1 cm to be a minimally clinically significant difference in pain score to show equivalence of periosteal block to IVRA. Based on prior study by Tageldin et al. the expected standard deviation in VAS in this population is 1.5 cm. Using 80% power and type-1 error rate of 0.05. We estimated that we would need a sample size of 78 patients. This will be increased to target enrollment of 90 patients to account for patient who decline consent or withdraw from the study.

Recruitment
Recruitment status
Recruiting
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] 9490 0
New Zealand
State/province [1] 9490 0

Funding & Sponsors
Funding source category [1] 298390 0
University
Name [1] 298390 0
University of Otago
Address [1] 298390 0
Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand
Country [1] 298390 0
New Zealand
Funding source category [2] 298471 0
Other Collaborative groups
Name [2] 298471 0
Health Research South
Address [2] 298471 0
Health Research South
PO Box 56
Dunedin 9054
Country [2] 298471 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 297519 0
None
Name [1] 297519 0
none
Address [1] 297519 0
none
Country [1] 297519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299382 0
HDEC
Ethics committee address [1] 299382 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299382 0
New Zealand
Date submitted for ethics approval [1] 299382 0
16/01/2018
Approval date [1] 299382 0
19/03/2018
Ethics approval number [1] 299382 0

Summary
Brief summary
Distal radius fractures are one of the most commonly encountered fractures in Emergency Medicine. Anaesthesia is typically required prior to manipulation of displaced fractures. Providers desire a technique that has a low risk of systemic side effects, is easy to learn and administer, and provides excellent anaesthesia. Recently Tageldin published a series of 42 patients who underwent a manipulation using a novel technique called the periosteal block. Using this technique anaesthetic is injected proximal to the fracture site in a ring around the bone. No patients in this observational study experience complications. Following the block 83% of patients reported manipulation was painless and 14% reported only minimal pain. The skill of learning these blocks was easy to acquire, and they were performed successfully by junior and senior members of the orthopaedic team.
This is a single centre, prospective, randomized clinical trial with consecutive recruitment of adult patients (16 years of age or older) presenting to the Dunedin Emergency Department with a distal radius fracture requiring manipulation. Consecutive patients with distal radius fractures deemed by the ED clinician to require closed reduction in the Emergency Department are eligible for enrollment. The hypothesis of the study is: Periosteal block performed by emergency physicians after brief training provides equivalent anaesthesia compared to IVRA during distal radius fracture manipulation.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80238 0
Dr Sierra Beck
Address 80238 0
Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 80238 0
New Zealand
Phone 80238 0
+64 211357760
Fax 80238 0
Email 80238 0
sierra.beck@otago.ac.nz
Contact person for public queries
Name 80239 0
Dr Sierra Beck
Address 80239 0
Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 80239 0
New Zealand
Phone 80239 0
+64 211357760
Fax 80239 0
Email 80239 0
sierra.beck@otago.ac.nz
Contact person for scientific queries
Name 80240 0
Dr Sierra Beck
Address 80240 0
Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand
Country 80240 0
New Zealand
Phone 80240 0
+64 211357760
Fax 80240 0
Email 80240 0
sierra.beck@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results