ANZCTR - Registration

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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

16/07/2021

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]

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

Condition category

Condition code

Anaesthesiology

Pain management

Injuries and Accidents

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Immediately following fracture reduction

Secondary outcome [1]

(ii) re-manipulation rates of the two techniques assessed by physician self reporting

Timepoint [1]

Assessed by questionnaire designed specifically for this study during ED visit

Secondary outcome [2]

(iii) provider assessment of ease of performance of the periosteal block compared to IVRA.

Timepoint [2]

Assessed by questionnaire designed specifically for this study during ED visit

Secondary outcome [3]

iv) emergency department length of stay for the two groups.

Timepoint [3]

Assessed by time stamps performed in electronic medical record during ED visit

Secondary outcome [4]

(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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/04/2018

Actual

1/05/2018

Date of last participant enrolment

Anticipated

2/01/2021

Actual

20/11/2020

Date of last data collection

Anticipated

2/01/2021

Actual

1/03/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Department of Medicine
9th Floor, Dunedin Hospital
Great King Street
Dunedin Central
Dunedin 9016
New Zealand

Country [1]

New Zealand

Funding source category [2]

Other Collaborative groups

Name [2]

Health Research South

Address [2]

Health Research South
PO Box 56
Dunedin 9054

Country [2]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

16/01/2018

Approval date [1]

19/03/2018

Ethics approval number [1]

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

Dr Sierra Beck

Address

Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 211357760

Fax

sierra.beck@otago.ac.nz

Contact person for public queries

Name

Sierra Beck

Address

Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 211357760

Fax

sierra.beck@otago.ac.nz

Contact person for scientific queries

Name

Sierra Beck

Address

Department of Medicine
Dunedin School of Medicine
PO Box 56
Dunedin 9054
New Zealand

Country

New Zealand

Phone

+64 211357760

Fax

sierra.beck@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Periosteal block versus intravenous regional anesthesia for reduction of distal radius fractures: A randomized controlled trial.	2022	https://dx.doi.org/10.1111/acem.14555

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically