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Trial registered on ANZCTR


Registration number
ACTRN12619001410145
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sub-Psoas Infiltration in the Emergency Department (SPIED). Comparing the pain relief provided by the three different nerve blocks currently in use for treating hip fractures in the emergency department.
Scientific title
Sub-Psoas Infiltration in the Emergency Department (SPIED). Ultrasound guided pericapsular nerve group block (PENG block) versus standard nerve blocks for the management of pain in patients with fractured neck of femur in the Lismore Base Hospital Emergency Department. A prospective observational study.
Secondary ID [1] 299335 0
None
Universal Trial Number (UTN)
U1111-1240-5858
Trial acronym
SPIED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured Neck of Femur 314481 0
Regional Anaesthesia 314482 0
Condition category
Condition code
Anaesthesiology 312814 312814 0 0
Pain management
Injuries and Accidents 312815 312815 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients with fractured neck of femur should receive regional anaesthesia in the emergency department. At present, three different techniques are in use in our department. This study will compare the analgesic efficacy of these three interventions:
1) Femoral nerve block
2) Fascia iliaca compartment block
3) Pericapsular nerve group block

There is no assignment of therapy. This is an observational study of current practice in the emergency department. It is expected that most or all nerve blocks will use 75 - 150 mg of ropivacaine in 20 - 40 mL. However alternative anaesthetic drug/dose/adjuncts may be used at the discretion of the clinician and her/his usual practice.

Patients will be observed for 12 hours after their nerve block or until checked in the operating theatre, whichever is sooner.
Intervention code [1] 315605 0
Not applicable
Comparator / control treatment
The intervention of primary interest is the pericapsular nerve group block. The femoral nerve block and fascia iliaca compartment block will be the comparators.
Control group
Active

Outcomes
Primary outcome [1] 321438 0
Change in pain score using the visual analogue scale (VAS) or pain assessment in advanced dementia (PAINAD) pain scale.
Timepoint [1] 321438 0
Pain scores will be documented prior to regional anaesthesia and for 12 hours after regional anaesthesia. Pain scores will be documented at 15, 30 and 60 minutes, then hourly.
Secondary outcome [1] 374943 0
Time of onset to analgesia.
Defined as the time of the first time at which a pain score (VAS or PAINAD) is recorded that is 1.5/10 less than the pain score prior to the block. As described in the study protocol
Timepoint [1] 374943 0
As described in the study protocol, pain scores will be measured at 15, 30, 60 minutes and then hourly for a total of 12 hours, or until the patient is checked in to the operating theatre, whichever is sooner.
Secondary outcome [2] 374944 0
Subjective observed patient comfort during nursing cares:
Nursing staff caring for patients will be asked to score the patient’s analgesia as adequate or inadequate during standard nursing cares that require movement. These may include:
Transfer to or from a bed
Transfer on and off a bedpan
Change of bedding or pad
Other painful patient movements at the discretion of the nursing staff.


This a composite secondary outcome. It will be documented on a single record sheet for each patient.
Timepoint [2] 374944 0
May or may not occur at any time within the data collection period. The data collection period is for 12 hours after the delivery of nerve block or until the patient is checked into the operating theatre, whichever is sooner.
Secondary outcome [3] 374945 0
Patient preference where cross over occurs and the patient receives a second form of regional anaesthesia in the pre-operative period.

Patients in whom cross over occurs will be identified by the acute pain service. The investigators, or the acute pain service on our behalf, will document which of the two blocks the patient found to be most effective at providing analgesia. This will be in the form of direct questioning by the investigators or the acute pain service on our behalf.

Other data including pain scores and opioid intake will be analysed if available.
Timepoint [3] 374945 0
Any time prior to arriving at operating theatre for surgical repair.
Secondary outcome [4] 374946 0
Block failure. As described in the protocol this is defined as not achieving a reduction in pain score (VAS or PAINAD) of 1.5 at any point in the data collection period. The data collection period is for 12 hours after the delivery of nerve block or until the patient is checked into the operating theatre, whichever is sooner.
Timepoint [4] 374946 0
As described in the protocol this is defined as not achieving a reduction in pain score (VAS or PAINAD) of 1.5 at any point in the data collection period. he data collection period is for 12 hours after the delivery of nerve block or until the patient is checked into the operating theatre, whichever is sooner.
Secondary outcome [5] 374947 0
Opioid Requirement. Measured by the electronic medical record and converted to oral mg of morphine using the faculty of pain medicine opioid calculator..
Timepoint [5] 374947 0
Opioid intake will be measured by analysis of the electronic medication chart from the insertion of block until 12 hours have passed, or the patient is checked in to the operating theatre, whichever occurs first.
This information will be converted to milligrams of oral morphine using the Faculty of Pain Medicine Opioid Calculator
Secondary outcome [6] 374952 0
Duration of analgesia. End of block effect is defined in the study protocol as an increase in pain score to < 1.0 from pre-block pain score in a patient who had a reduction in pain score of > 1.5 at any time.
Timepoint [6] 374952 0
Assessment is as described in the protocol and above. At 15, 30, 60 minutes after block and hourly thereafter for up to 12 hours or until the patient is checked in the operating theatre.

Eligibility
Key inclusion criteria
Inclusion Criteria
1. Adult patients (>18 years) presenting to Lismore Base Hospital Emergency Department with radiologically confirmed #NOF. The neck of femur fractures include:
a. Sub-capital fracture
b. Surgical neck fracture
c. Intertrochanteric fracture
d. Peritrochanteric fracture
2. The patient receives a nerve block for their fractured neck of femur in the Lismore Base Hospital Emergency Department
3. The nerve block may occur before or after the radiological confirmation of diagnosis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
Regional anaesthesia not provided in the Lismore Base Hospital Emergency Department
Allergy to amide local anaesthetics
Infection of the skin overlying at the overlying the site of potential nerve block
The patient has already received a nerve block for this fracture prior to arrival in at Lismore Base Hospital
Other reason at the discretion of clinician/s
Femoral shaft fracture

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Primary Outcome:
Reduction in pain scores over the first 12 hours after nerve block. We will apply the following statistical tests:
Students t-test to compare the reduction in pain score of patients who receive a PENGB compared to FNB and FICB
Subgroup analyses of the cognitively impaired and non-cognitively impaired population. These populations will have pain scored by the PAINAD and VAS respectively.
Subgroup analysis of FNB and FICB separately

Secondary Outcomes

Onset of block. Defined as the time until the first pain score > 1.5 less than the pre-block pain score.
T-test

Subjective observed patient comfort during nursing cares
Chai Square test

Patient Preference in the event of crossover
Chai Square test

Rates of block failure. Defined as not achieving a reduction in pain score of > 1.5 / 10
Chai square test

Duration of analgesia. End of block effect defined as an increase in pain on movement score to < 1.0 from pre-block pain score for that patient, in a patient who had a reduction in pain score on movement > 1.5 at any time.
T-test

Recruitment
Recruitment status
Not yet 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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14814 0
Lismore Base Hospital - Lismore
Recruitment postcode(s) [1] 28064 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 303852 0
Hospital
Name [1] 303852 0
Lismor Base Hospital
Address [1] 303852 0
Emergency Department
Lismore Base Hospital
Uralba Street
Lismore
NSW 2480
Country [1] 303852 0
Australia
Primary sponsor type
Hospital
Name
Lismore Base Hospital
Address
Uralba Street
Lismore
NSW 2480
Country
Australia
Secondary sponsor category [1] 303988 0
None
Name [1] 303988 0
Address [1] 303988 0
Country [1] 303988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304364 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 304364 0
PO Box 821
Murwillumbah
NSW 2484
Ethics committee country [1] 304364 0
Australia
Date submitted for ethics approval [1] 304364 0
10/08/2019
Approval date [1] 304364 0
11/10/2019
Ethics approval number [1] 304364 0
2019/ETH12693

Summary
Brief summary
The purpose of the study is to compare the effectiveness of three different techniques for regional anaesthesia (nerve blocks) that are currently used by doctors in the Emergency Department at Lismore Base Hospital. The study is primarily interested in confirming the effectiveness of the pericapsular nerve group block (PENG block) which has recently entered clinical practice. It has a sound scientific basis and anecdotally it appears to be a very effective block, but there is not yet published evidence comparing it's effect to that of the other nerve blocks in use: the femoral nerve block and fascia iliaca compartment block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96694 0
Dr Alby Fahey
Address 96694 0
Emergency Department
Lismore Base Hospital
Uralba Street
Lismore
NSW 2480
Country 96694 0
Australia
Phone 96694 0
+61401936741
Fax 96694 0
Email 96694 0
alan.fahey@gmail.com
Contact person for public queries
Name 96695 0
Dr Alby Fahey
Address 96695 0
Emergency Department
Lismore Base Hospital
Uralba Street
Lismore
NSW 2480
Country 96695 0
Australia
Phone 96695 0
+61401936741
Fax 96695 0
Email 96695 0
alan.fahey@gmail.com
Contact person for scientific queries
Name 96696 0
Dr Alby Fahey
Address 96696 0
Emergency Department
Lismore Base Hospital
Uralba Street
Lismore
NSW 2480
Country 96696 0
Australia
Phone 96696 0
+61401936741
Fax 96696 0
Email 96696 0
alan.fahey@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data = raw line-by-line data collected from each participant.
All collected data will be available to be shared
When will data be available (start and end dates)?
From the time of first presentation or publishing of study results. Until 5 years after completion of the study.
Available to whom?
Interested parties who contact the principal investigator by email for the purposes of performing their own analysis of the data or to inform future research.
Available for what types of analyses?
No specific restrictions to the data analyses for which data will be released.
How or where can data be obtained?
By email request to the principal investigator: alan.fahey@gmail.com
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4931 0
Ethical approval
Citation [1] 4931 0
Link [1] 4931 0
Email [1] 4931 0
NNSWLHD-Ethics@health.nsw.gov.au
Other [1] 4931 0
Confirmation of ethics approval can be obtained from Rebecca Lavery at the email address above on behalf of the Northern NSW Human Research Ethics Committee.

"Date of Decision Notification: 11 Oct 2019

Dear Alby Fahey,

Thank you for submitting the following Human Research Ethics Application (HREA) for HREC review;

2019/ETH12693 (Local Ref: LNR249): Sub-Psoas Infiltration in the Emergency Department (SPIED). Ultrasound guided pericapsular nerve group block (PENG block) versus standard nerve blocks for the management of pain in patients with fractured neck of femur in the Lismore Base Hospital Emergency Department. A prospective observational study.

This project was considered by a delegate of the North Coast NSW Human Research Ethics Committee on 11/10/2019 and was determined to meet the requirements of the National Statement on Ethical Conduct in Human Research (2007).

This project has been Approved to be conducted at the following sites:
Lismore Base Hospital"


Attachment [1] 4931 0
Type [2] 4936 0
Study protocol
Citation [2] 4936 0
Link [2] 4936 0
Email [2] 4936 0
Other [2] 4936 0
Summary results
No Results