RecruitingACTRN12625000839404

Older Adults with Broken Ribs: Testing a Numbing Injection Near the Spine (Erector Spinae Plane Block) and the Impact on Breathing and Pain

Efficacy of the Erector spinae plane block with Catheter for Analgesia post Rib fracture among Elderly patients (E-CARE - I): a randomised pilot study


Sponsor

Richard Buckley, Monash Health.

Enrollment

40 participants

Start Date

Apr 21, 2026

Study Type

Interventional

Conditions

Summary

Older adults often struggle to breathe deeply after breaking ribs because pain makes every breath hurt. This study will test whether adding an ultrasound-guided erector spinae plane (ESP) block—a small catheter that drips numb­ing medicine beside the spine—can improve breathing and comfort beyond what usual pain medicines alone achieve. Forty patients aged 65 years or older with recent rib fractures will be randomly allocated to (1) ESP catheter + standard medicines or (2) standard medicines alone. Lung function metrics; FEV1, PEFR and FVC, will be checked with a hand-held spirometer before treatment and once daily for five days, and participants will be phoned at 30 days to discuss their recovery. Study hypothesis: patients who receive the ESP catheter will show a greater day-to-day improvement in lung function, report less pain, and need fewer opioids than those receiving standard care alone.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Inclusion Criteria7

  • 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.

Exclusion Criteria19

  • 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.

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Interventions

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 t

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.


Locations(1)

Dandenong Hospital- Monash Health - Dandenong

VIC, Australia

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