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Trial registered on ANZCTR


Registration number
ACTRN12620000370909
Ethics application status
Approved
Date submitted
2/03/2020
Date registered
17/03/2020
Date last updated
10/12/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the clinical efficacy of the Pericapsular Nerve Group (PENG) block in hip fracture surgery
Scientific title
A single centre prospective cohort study to assess the clinical efficacy of the Pericapsular Nerve Group (PENG) block in hip fracture surgery
Secondary ID [1] 300689 0
none
Universal Trial Number (UTN)
U1111-1248-6660
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neck of femur fracture 316500 0
Condition category
Condition code
Injuries and Accidents 314745 314745 0 0
Fractures
Anaesthesiology 314746 314746 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Arm 1 - Prospectively observe the effect of the Pericapsular Nerve Group (PENG) block on patients undergoing surgical repair of fractured neck of femur. Collect pre and postoperative pain scores, opioid consumption, length of hospital stay, quadriceps strength, and patient satisfaction. Participants are observed during the block performance, postoperatively in recovery and on day one postoperatively on the ward. Please note, the patients in this cohort would still receive the PENG in the absence of the study. There is no participant involvement required for this cohort as this is an observational study only.
Arm 2 - Compare arm 1 with a retrospectively observed patient cohort who received a femoral nerve block as part of the pain management plan for surgical repair of fractured neck of femur. Collect pre and postoperative pain scores, opioid consumption, length of hospital stay, quadriceps strength, and patient satisfaction. All of this information is collected from the patient notes and there is no participant involvement required for this cohort as this is an observational study only.
Intervention code [1] 317015 0
Not applicable
Comparator / control treatment
Traditionally, patients undergoing surgical repair of their fractured neck of femur receive a femoral nerve regional block as part of their multimodal pain management. This historical group of patients who received their surgery between October 2019 and April 2020 at Flinders Medical Centre (the same institution as the prospective group) will be observed retrospectively through case note review (available through medical records) for pre and postoperative pain scores, opioid consumption, length of hospital stay, quadriceps strength, and patient satisfaction.
Control group
Historical

Outcomes
Primary outcome [1] 323096 0
Measure the numeric pain score reduction with the PENG hip block compared with patients receiving femoral nerve blockusing the Visual Analogue Scale (VAS)
Timepoint [1] 323096 0
Day 1 postoperative
Secondary outcome [1] 380765 0
Measure opioid use in patients receiving the PENG hip block compared with patients receiving femoral nerve block. This information will be obtained from the patient drug chart (to include any oxycodone, fentanyl, morphine, and tramadol received) and converted to Morphine Equivalents using the Australia New Zealand College of Anaesthetists and Pain Medicine Opioid Calculator app.
Timepoint [1] 380765 0
Up to and including day 3 postoperative
Secondary outcome [2] 380766 0
Record quadriceps weakness post-operatively in patients receiving the PENG block compared with patients receiving femoral nerve block. This information will be measured clinically by assessing a straight leg raise and knee extension test on each patient per the Neurological Motor Scale 0-5.
Timepoint [2] 380766 0
Day 1 postoperative

Eligibility
Key inclusion criteria
Age >44
Undergoing surgical repair of fractured neck of femur
Eligible to receive a regional anaesthesia nerve block
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <45
Contradiction to receiving a regional anaesthesia nerve block (anticoagulant use, local anaesthetic toxicity or allergy, infection at site of injection)
Patient refusal for block

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis
Analysis of results
Data will be analysed on an ongoing basis using SPSS 24.0 (IBM, NY, USA) or a similar program by one researcher. A statistician will be consulted at 2 time points (after data of 10 and 24 patients have been collected) to assure high standards of statistical analysis.
Statistical methods:
Categorical data collected from the study will be described as numbers and percentages and analysed using the chi-square test. Continuous data shall be expressed as means with standard deviations and compared using the Student’s t-test. Logistic regression analysis shall be enlisted to evaluate the effect of the PENG block on pain and opiate consumption. A 95% confidence interval will be provided for the odds and hazard ratios. A significant p-value shall be considered as <0.05 (two-sided). All above analyses shall be performed using the SPSS 24.0 statistical software.

Sample size requirements
Total: N=24
Samples sizes have been calculated using PASS 14 Power Analysis and Sample Size Software (2015). NCSS, LLC. Kaysville, Utah, USA (ncss.com/software/pass).
We calculated power based on a pain score reduction of 3 out of 10, which is the difference between 3.4 and 7, rounded up to increase margin of safety.
By using an effect size of a pain score reduction of 3 out of 10, with a standard deviation of 2, in the study population with a two-sided 5% significance level and 95% power, this gives an estimated number of 24 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
1/04/2020
Actual
1/04/2020
Date of last data collection
Anticipated
31/05/2020
Actual
31/05/2020
Sample size
Target
24
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16045 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 29558 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305133 0
Hospital
Name [1] 305133 0
Flinders Medical Centre
Country [1] 305133 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive, Bedford Park South Australia 5042
Country
Australia
Secondary sponsor category [1] 305493 0
None
Name [1] 305493 0
none
Address [1] 305493 0
no other funding. Mandatory fields, requiring entry, therefore unable to leave blank
Country [1] 305493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305503 0
Southern Adelaide Local Health Network Research Committee
Ethics committee address [1] 305503 0
Flinders Drive, Bedford Park, South Australia 5042
Ethics committee country [1] 305503 0
Australia
Date submitted for ethics approval [1] 305503 0
09/09/2019
Approval date [1] 305503 0
09/10/2019
Ethics approval number [1] 305503 0
AR/19/SAC/197

Summary
Brief summary
Hip fractures are a common presentation to hospital in the elderly associated with significant morbidity and mortality. To reduce hip fracture associated morbidity and mortality it has been recommended that patients receive frequent pain assessment, multimodal analgesia and adequate analgesia to allow mobilisation day one post-operatively. Part of a balanced multimodal analgesia plan includes performing a regional nerve block such as a femoral nerve block or a fascia iliac nerve block to reduce the requirement for opioid analgesia, potentially reduced rates of delirium, and facilitate early mobilization provided they do not cause motor weakness. The current standard in treatment for regional anaesthesia is a femoral nerve block, however studies have not shown a great clinical reduction in pain scores and there is associated quadriceps muscle weakness potentially delaying mobility after surgery. This had led to an interest in the development of a regional nerve block which produces a more significant reduction in pain without causing motor weakness. An anatomical study in 2018 explored the sensory innervation of the hip joint which has led to the development of the Pericapsular Nerve Group (PENG) block, first described in the literature in late 2018. The literature surrounding PENG blocks is so far limited to small case series and editorials, however the reported studies show potentially positive results of improved pain scores and potentially a reduction in quadriceps weakness. The aim of this feasibility study was to evaluate the impact of this new regional technique on pain scores, opioid use, and quadriceps strength compared to the femoral nerve block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100590 0
Dr Brigid Brown
Address 100590 0
Department of Anaesthesia
Level 2 Flinders Medical Centre
Flinders Drive, Bedford Park, South Australia 5042
Country 100590 0
Australia
Phone 100590 0
+61 401588434
Fax 100590 0
Email 100590 0
[email protected]
Contact person for public queries
Name 100591 0
Brigid Brown
Address 100591 0
Department of Anaesthesia
Level 2 Flinders Medical Centre
Flinders Drive, Bedford Park, South Australia 5042
Country 100591 0
Australia
Phone 100591 0
+61 401588434
Fax 100591 0
Email 100591 0
[email protected]
Contact person for scientific queries
Name 100592 0
Brigid Brown
Address 100592 0
Department of Anaesthesia
Level 2 Flinders Medical Centre
Flinders Drive, Bedford Park, South Australia 5042
Country 100592 0
Australia
Phone 100592 0
+61 401588434
Fax 100592 0
Email 100592 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7281Ethical approval  [email protected]



Results publications and other study-related documents

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