Multiple rib fractures Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >=16 years with unilateral or bilateral >=3 rib fractures following blunt chest trauma 2. Injury occurred <=72 hours of hospital admission
Exclusion criteria
Exclusion criteria: 1. Severe traumatic brain injury with a predicted ventilatory requirement >7 days 2. Acute quadriparesis 3. Spinal fracture precluding mobilisation 4. Penetrating trauma or open rib fractures 5. Upper airway injury requiring intubation and mechanical ventilation with an expected dependency of more than 5 days (e.g. tracheal disruption) 6. Any chest wall injuries that preclude a catheter insertion 7. Not anticipated to survive >= 48 hours 8. Contamination or infection at site of potential SAP insertion 9. Any contraindication for the treating clinician for SAP block catheter insertion 10. Patients of childbearing age who have tested positive for pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New diagnosis of pneumonia, as agreed by a blinded end point assessment committee, five days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain assessed using a numerical rating scale (0-10), recorded every 4 hours, day 1 to 5, day 14 and before discharge, and by the patient-reported BPI at one and three-months post-randomisation. 2. Ventilatory function measured by incentive spirometry and peak expiratory flow twice a day via the daily assessment log until discharge 3. Number of days ventilated and the requirement for invasive/non-invasive methods 4. 30 day and 3 month mortality 5. Complications and safety data associated with SAP 6. Opiate consumption such as morphine and related compounds (daily until discharge and at 1 and 3 months post randomisation) 7. Length of stay in hospital and critical care level two/three facility 8. Hospital re-admission within 30 days of discharge 9. Patient-Reported Outcome Measures (PROMs) at 1 and 3 months: 9.1. Qulaity of life: EQ-5D-5L 9.2. Medical Research Council (MRC) dyspnoea scale at 3 months only 9.3. Brief Pain Index (BPI) 9.4. McGill Pain Questionnaire (SF-MPQ-2) | — |
Countries
England, United Kingdom