Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000298910
Ethics application status
Approved
Date submitted
16/09/2019
Date registered
4/03/2020
Date last updated
4/03/2020
Date data sharing statement initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Control Trial comparing PENG (PEricapsular Nerve Group) block to femoral nerve block in patients with a neck of femur fracture
Scientific title
Randomized Control Trial comparing PENG (PEricapsular Nerve Group) block to femoral nerve block in patients with a neck of femur fracture
Secondary ID [1] 299270 0
Nil known
Universal Trial Number (UTN)
U1111-1240-1404
Trial acronym
PENG RCT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
neck of femur fracture 314405 0
post-operative pain 314406 0
delirium 314407 0
Condition category
Condition code
Anaesthesiology 312739 312739 0 0
Pain management
Anaesthesiology 312740 312740 0 0
Anaesthetics
Injuries and Accidents 312741 312741 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PENG (PEricapsular Nerve Group) hip block
Patient consent shall be obtained, and an information sheet and patient consent form provided.
The intervention is a hip block, either the trial intervention which is the pericapsular nerve group block or the gold standard which is a femoral nerve block
This shall be performed by experienced consultant anaesthetists
The medication used is ropivicaine. Dose and concentration up to anaesthetist. Data shall be collected about the dose and concentrations. There are no maximum or minimum doses/concentrations prescribed.
Equipment used for the regional block is a Sonoplex needle and ultrasound
This block is a once off stat dose intra-op, given in operating theatres during surgery.
Intervention code [1] 315555 0
Treatment: Other
Comparator / control treatment
Femoral nerve block vs PENG block

Two different hip blocks. PENG block is much newer, and up against the bone of the acetabulum. The PENG block is a fascial block. This is the trial intervention.
Femoral nerve block is perineural around the femoral nerve, this is the control intervention.
Control group
Active

Outcomes
Primary outcome [1] 321377 0
Pain score- visual analogue scale.
Timepoint [1] 321377 0
Baseline, immediately post-operatively (primary endpoint) and Day 1 post-operatively
Secondary outcome [1] 374820 0
Mental health, by means of the Quality of Recovery validated questionnaire and the Brief Pain iknventory validated Questionnaire. Both are conducted on day 1
Timepoint [1] 374820 0
Once off on ward post-op on day 1
Secondary outcome [2] 374821 0
Opiate requirement in morphine equivalents, this is assessed by data collection from the medication chart
Timepoint [2] 374821 0
Peri-operative, post-op in Recovery, and day 1 on the ward

Eligibility
Key inclusion criteria
NOF (Neck of Femur fracture) patients aged over 45 years, able to give first party consent
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to regional anaesthesia, unable to give first party consent

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)
Triple blind, to patient, surgeon and pain team. Randomized via online randomization program. Allocation is concealed via central randomization via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomized via online randomization program.
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
20/11/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14787 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 28018 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 303802 0
Hospital
Name [1] 303802 0
Flinders Medical Centre, in kind for staff time
Country [1] 303802 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country
Australia
Secondary sponsor category [1] 303924 0
None
Name [1] 303924 0
-
Address [1] 303924 0
-
Country [1] 303924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304321 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 304321 0
Ethics committee country [1] 304321 0
Australia
Date submitted for ethics approval [1] 304321 0
01/10/2019
Approval date [1] 304321 0
01/02/2020
Ethics approval number [1] 304321 0
218.19

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

Contacts
Principal investigator
Name 96530 0
Dr D-Yin Lin
Address 96530 0
c/o Department of Anaesthesia
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 96530 0
Australia
Phone 96530 0
+61 434001819
Fax 96530 0
Email 96530 0
[email protected]
Contact person for public queries
Name 96531 0
D-Yin Lin
Address 96531 0
c/o Department of Anaesthesia
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 96531 0
Australia
Phone 96531 0
+61 434001819
Fax 96531 0
Email 96531 0
[email protected]
Contact person for scientific queries
Name 96532 0
D-Yin Lin
Address 96532 0
c/o Department of Anaesthesia
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 96532 0
Australia
Phone 96532 0
+61 434001819
Fax 96532 0
Email 96532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not necessary. Only pooled data shall be used for group analysis.


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
No additional documents have been identified.