Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000839404p
Ethics application status
Submitted, not yet approved
Date submitted
14/07/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Older Adults with Broken Ribs: Testing a Numbing Injection Near the Spine (Erector Spinae Plane Block) and the Impact on Breathing and Pain
Scientific title
Efficacy of the Erector spinae plane block with Catheter for Analgesia post Rib fracture among Elderly patients (E-CARE - I): a randomised pilot study
Secondary ID [1] 314900 0
None
Universal Trial Number (UTN)
Trial acronym
E-CARE-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib Fractures 338206 0
Condition category
Condition code
Anaesthesiology 334481 334481 0 0
Pain management
Injuries and Accidents 334564 334564 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
erector spinae plane (ESP) catheter plus standard analgesia
Within 24 h of enrolment an anaesthetist performs an ultrasound-guided ESP block on the fractured-rib side. A Tuohy needle is placed onto the transverse process and 20 mL of 0.2 % ropivacaine is injected beneath the erector-spinae muscle. A multi-orifice catheter is then threaded 3–4 cm and connected to an ambulatory pump.

Total duration of ESP-catheter delivery – The ambulatory pump is pre-programmed to give 20 mL of 0.2 % ropivacaine bolus then every four hours for a maximum of 96 h (4 days). The Acute Pain Service (APS) reviews the site and pump settings each morning and will remove the catheter earlier if (i) local infection, leakage or dislodgement is suspected, (ii) analgesia is no longer required, or (iii) the treating anaesthetist believes continuing infusion offers no further benefit.

Every day the participant will have an assessment with a Starkmed (Atarmon, NSW, Australia) Portable spirometer and undergo 3 attempts at the best deep breath and forced expiration. This will be to measure FEV1, PEFR and FVC. This will occur every day the patient is in hospital for a maximum of 5 days. This is different to laboratory measurements as the device is portable. This starkmed data will be compared to the laboratory measurements for equivalence.

Strategies to monitor adherence/fidelity –
• Daily APS ward-round checklist confirms: correct pump program, reservoir volume consistent with expected delivery, intact dressings, and dermatomal “block-to-ice” spread.
• The pump’s electronic event log is downloaded on removal and compared with the infusion schedule.
• Research staff audit medication charts, nursing progress notes and REDCap fields for “Analgesic medication class and dose taken”, “Total ropivacaine delivered”, and “Protocol adherence – correct pump settings”.
• Feasibility targets (greater than 60 % catheters in situ for equal to 5 days; 100 % correct pump settings) are reported with 95 % CIs in the pilot analysis pla.

Status of guideline multimodal analgesia – The oral/IV drug protocol is standard care, not part of the investigational intervention. Standard care for rib-fracture patients at our centre is a predefined multimodal analgesia bundle that is entirely independent of the study intervention. Every participant receives regular paracetamol 1 g orally every six hours and, provided there are no renal or other contraindications, celecoxib 200 mg orally twice daily. Break-through pain is managed with immediate-release oral opioids—oxycodone 2.5–10 mg every three hours, tramadol 50–100 mg every six hours, or sublingual buprenorphine 100–400 µg every four hours—with escalation to an intravenous patient-controlled analgesia pump (fentanyl or oxycodone) if oral therapy is inadequate. Where severe pain continues to compromise ventilation, the treating team may commence a low-dose ketamine infusion at 0.1–0.2 mg per kg per h. All medications are charted in the electronic medical record, reviewed during the daily Acute Pain Service ward round, and the class and dose of every analgesic are captured in the REDCap case-report form, giving the research team an objective audit of protocol adherence. Because this regimen is embedded in routine ward practice and is provided to both study arms, it represents usual care rather than an additional element of the research intervention.
Intervention code [1] 331506 0
Treatment: Drugs
Intervention code [2] 331550 0
Treatment: Other
Comparator / control treatment
Control arm – standard multimodal analgesia alone, no ESP catheter.

Every participant (control and intervention) will be measured with spirometry post randomisation every day, for up to 5 days whilst an inpatient. This will be done with the portable spirometer

Every participant will receive a single laboratory assessment with spirometry equipment that has been calibrated, that will be done along side the portable spirometry and will occur on any day whilst an inpatient. This will be FEV1, FVC and PEFR.

The multimodal drug regimen described in the protocol is ordinary ward practice, not a study-specific intervention, and it is applied identically to control and ESP-catheter participants. On admission every patient is charted regular paracetamol 1 g orally six-hourly and, where no contraindications exist, celecoxib 200 mg orally twice daily. Break-through pain is covered by nurse-administered immediate-release oral opioids—oxycodone 2.5–10 mg every three hours, tramadol 50–100 mg every six hours, or sublingual buprenorphine 100–400 µg every four hours—with escalation to an intravenous patient-controlled analgesia pump (fentanyl or oxycodone) if oral therapy proves inadequate. When severe discomfort continues to limit ventilation despite these measures, the treating team may add a low-dose ketamine infusion at 0.1–0.2 mg kg per h. All of these drugs are given only for the duration of the inpatient episode (typically three to seven days) and are logged automatically in the electronic medication administration record; adherence is verified each morning during the Acute Pain Service round and cross-checked by research staff against the case-report form, obviating the need for pill counts or laboratory assays. Because this written protocol pre-dated the study and remains available irrespective of randomisation, it constitutes standard care rather than part of the investigational intervention
Control group
Active

Outcomes
Primary outcome [1] 342179 0
To assess the feasibility of this pilot: recruitment of participants
Timepoint [1] 342179 0
End of study period.
Primary outcome [2] 342180 0
To assess the acceptability of the trial by participants.
Timepoint [2] 342180 0
30 days post recruitment.
Primary outcome [3] 342243 0
Retention rate (Primary Outcome)
Timepoint [3] 342243 0
End of study
Secondary outcome [1] 449823 0
To understand if bedside spirometry Is equivalent compared to lab-based measurements to measure respiratory outcomes for subsequent trial. FVE1 will be compared to lab equipment.
Timepoint [1] 449823 0
Repeated measurements once daily from baseline (pre-intervention, Day 0) to Day 5 inclusive.
Secondary outcome [2] 450068 0
adherence of staff to the protocol (primary outcome)
Timepoint [2] 450068 0
End of study
Secondary outcome [3] 450328 0
Adherence of participants to research protocol
Timepoint [3] 450328 0
End of study,
Secondary outcome [4] 450623 0
To understand if bedside spirometry Is equivalent compared to lab-based measurements to measure respiratory outcomes for subsequent trial. FVC will be compared to lab equipment.
Timepoint [4] 450623 0
Repeated measurements once daily from baseline (pre-intervention, Day 0) to Day 5 inclusive.
Secondary outcome [5] 450624 0
To understand if bedside spirometry Is equivalent compared to lab-based measurements to measure respiratory outcomes for subsequent trial. PEFR will be compared to lab equipment.
Timepoint [5] 450624 0
Repeated measurements once daily from baseline (pre-intervention, Day 0) to Day 5 inclusive.

Eligibility
Key inclusion criteria
• Age 65+ years.
• Blunt thoracic trauma.
• Radiological evidence of acute rib fractures.
• FVC less than 45% of predicted normal.
• Hospital admission for rib fractures.
• Referral to the Acute Pain Service (APS) for intervention within 24 hours.
• Injury in the preceding 48 hours.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Bilateral rib fractures.
• Sternal fractures.
• Patients who are not fluent in English language.
• Pulmonary contusion.
• Hemothorax with ICC.
• Pneumothorax with ICC.
• Distracting extra thoracic fractures.
• Major trauma mechanism that would suggest injuries other than unliteral chest wall.
• Weight less than 45 kg.
• Acute delirium defined as a 4AT more than 3.
• Absolute contraindications to regional techniques such as allergy or infection over insertion site.
• Decompensated hepatic failure
• Decompensated heart failure requiring active management
• Severe airways disease:
• COPD which is a threat to life e.g. home oxygen, NIV
• Active Asthma which might affect study measurements
• Severe Interstitial lung disease which is a threat to life e.g. home oxygen.
• Motor neuron disease - known diagnosis alone.
• Motor Neuron Disease or severe neuromuscular condition which would preclude study measurements.

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)
Allocation is concealed - central randomisation by computer program online.
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
This feasibility study will enrol 20 participants, yielding 20 paired comparisons between the handheld spirometer and the laboratory spirometer. Using a paired two-one-sided-test (TOST) framework (a = 0.05 for each one-sided test ? 90 % CI), equivalence will be concluded if the mean within-subject difference lies entirely within ±100 mL for the respiratory parameters being measured (FEV1, FVC, PEFR). This calculation assumes a within-pair SD of 150 mL, 20 pairs provide ˜80 % power to demonstrate equivalence (calculated with the TOSTER package in R). The primary purpose remains to assess feasibility and refine trial procedures rather than to estimate treatment effects precisely; the chosen sample size is therefore both operationally practical and statistically adequate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/01/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28212 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment postcode(s) [1] 44424 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 319461 0
Self funded/Unfunded
Name [1] 319461 0
Country [1] 319461 0
Primary sponsor type
Individual
Name
Richard Buckley, Monash Health.
Address
Country
Australia
Secondary sponsor category [1] 321951 0
Individual
Name [1] 321951 0
Inamul Rahiman, Monash Health.
Address [1] 321951 0
Country [1] 321951 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318035 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318035 0
Ethics committee country [1] 318035 0
Australia
Date submitted for ethics approval [1] 318035 0
23/07/2025
Approval date [1] 318035 0
Ethics approval number [1] 318035 0

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

Contacts
Principal investigator
Name 142914 0
Dr Richard Buckley
Address 142914 0
Dandenong Hospital, 135 David St, Dandenong VIC 3175
Country 142914 0
Australia
Phone 142914 0
+610448227641
Fax 142914 0
Email 142914 0
[email protected]
Contact person for public queries
Name 142915 0
Richard Buckley
Address 142915 0
Dandenong Hospital, 135 David St, Dandenong VIC 3175
Country 142915 0
Australia
Phone 142915 0
+610395541000
Fax 142915 0
Email 142915 0
[email protected]
Contact person for scientific queries
Name 142916 0
Richard Buckley
Address 142916 0
Dandenong Hospital, 135 David St, Dandenong VIC 3175
Country 142916 0
Australia
Phone 142916 0
+610395541000
Fax 142916 0
Email 142916 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.