ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

Fractures

Anaesthesiology

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]

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]

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]

Day 1 postoperative

Secondary outcome [1]

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]

Up to and including day 3 postoperative

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre

Address [1]

Department of Anaesthesia Level 2 Flinders Medical Centre Flinders Drive Bedford Park, SA 5042

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive, Bedford Park South Australia 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

no other funding. Mandatory fields, requiring entry, therefore unable to leave blank

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Local Health Network Research Committee

Ethics committee address [1]

Flinders Drive, Bedford Park, South Australia 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/09/2019

Approval date [1]

09/10/2019

Ethics approval number [1]

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

Dr Brigid Brown

Address

Department of Anaesthesia Level 2 Flinders Medical Centre Flinders Drive, Bedford Park, South Australia 5042

Country

Australia

Phone

+61 401588434

Fax

[email protected]

Contact person for public queries

Name

Brigid Brown

Address

Department of Anaesthesia Level 2 Flinders Medical Centre Flinders Drive, Bedford Park, South Australia 5042

Country

Australia

Phone

+61 401588434

Fax

[email protected]

Contact person for scientific queries

Name

Brigid Brown

Address

Department of Anaesthesia Level 2 Flinders Medical Centre Flinders Drive, Bedford Park, South Australia 5042

Country

Australia

Phone

+61 401588434

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7281	Ethical approval			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically