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A two-arm pragmatic randomised control trial comparing the clinical and cost-effectiveness of serratus anterior plane block (SAP) in reducing the rate of respiratory infections 5 days post randomisation in patients with multiple rib fractures (MRF) when compared with the usual care in the NHS trauma setting

A pragmatic randomised controlled trial evaluating the clinical and cost-effectiveness of serratus anterior plane block with catheter insertion compared to usual care in patients with multiple rib fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16156075
Enrollment
824
Registered
2022-10-24
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple rib fractures Surgery

Interventions

Participant will be asked to rate their pain on a numerical scale and donate a blood sample for future research use. Researchers will enter the baseline data in the secure online database and the com

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
New diagnosis of pneumonia, as agreed by a blinded end point assessment committee, five days after randomisation

Secondary

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026