Erector spinae plane blocks for the early analgesia of rib fractures in trauma Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Randomisation will be performed to a 1:1 ratio using a web-based automated computer-generated minimisation with treatment groups balanced for: age, gender, polytrauma and unilateral or bilateral rib f
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/10/2023: 1. 18 years and older 2. New admission to major trauma centre and can receive trial intervention 3. Mechanism of injury blunt thoracic trauma 4. Radiographic evidence of 1 or more new traumatic rib fractures 5. Moderate or severe unilateral acute pain (defined as 11-point numerical rating scale (NRS) pain >4 when patient performing vital capacity breath or effective cough) at time of enrolment. Patients may have bilateral fractures, but pain must be unilateral _____ Previous inclusion criteria: 1. 18 years and older. 2. New admission to major trauma centre and can receive trial intervention within 12 hours of admission 3. Mechanism of injury blunt thoracic trauma 4. Radiographic evidence of 1 or more new traumatic rib fractures 5. Moderate or severe unilateral acute pain (defined as 11-point numerical rating scale (NRS) pain >4 when patient performing vital capacity breath or effective cough) at time of enrolment. Patients may have bilateral fractures, but pain must be unilateral
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/10/2023: 1. Patient refusal or inability to give informed written consent for any reason 2. Thoracic injury requiring emergent operative or interventional radiology management 3. Allergy to local anaesthetic 4. Infection at site of ESP block 5. Actual or estimated total body weight 50kg or less thereby precluding safe dosing of local anaesthetic for ESP block _____ Previous exclusion criteria: 1. Patient refusal or inability to give informed written consent for any reason 2. Thoracic injury requiring emergent operative or interventional radiology management 3. Allergy to local anaesthetic 4. Infection at site of ESP block 5. Actual or estimated total body weight 50 kg or less the,reby precluding safe dosing of local anaesthetic for ESP block. 6. Current or recent involvement in other clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility primary outcome measures: 1. Recruitment rate – using trial database – measured at the end of the trial recruitment period 2. Retention rate – measured using trial database – measured at the end of the trial follow-up period 3. Barriers and facilitators to recruitment and retention among participants and recruitment site staff (anaesthetists, allied health professionals, surgeons and research staff) with regard to the acceptability of the trial intervention – measured using interviews, qualitative assessment Feasibility secondary outcome measures measured at the end of the trial follow-up period: 4. Willingness of anaesthetists to randomise patients to intervention or control and willingness of potential participants to randomisation – measured using recruitment logs and interviews 5. Causes of protocol violation and trial withdrawal – measured using trial logs and interviews 6. Completeness of data arising from the trial - measured using database 7. Fidelity of the trial intervention in terms of ESP catheter dislodgement, blockage or other technical failure - measured using CRFs/database 8. Acceptability of the intervention to participants – measured using questionnaires and interviews 9. Complications of the intervention – recorded on AE/SAE log and database | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Baseline demographics 2. Static chest wall pain (SF-MPQ-2) at baseline, 24, 48, 72 hours 3. Dynamic chest wall pain (modified functional pain scale) at baseline, 24, 48, 72 hours 4. Spirometry (Forced vital capacity) at baseline, 3, 6, 9, 12, 24, 48, 72 hours 5. Analgesic consumption measured using hospital drug chart at baseline(cumulative dose 24 hours prior to receiving intervention), then again at 24, 48 and 72 hours post-intervention 6. Opioid-related side-effects measured at baseline, 24, 48, 72 hours using: 6.1. Constipation, defined as the absence of bowel movement in the preceding 24-hour period 6.2. Nausea or vomiting, scored on a 5-point scale (0 = no nausea or vomiting; 1 = mild nausea, no treatment required; 2 = nausea, anti-emetic administered; 3 = vomiting, anti-emetics administered; 4 = nausea or vomiting unresponsive to anti-emetic therapy) 6.3. Pruritis scored on an 11-point numerical rating scale 6.4. Opioid-induced sedation, scored on the Modified Observer’s Assessment of Alertness/Sedation scale 7. Additional RA procedures at baseline, 24, 48 and 72 hours will be recorded on CRFs 8. Complications of RA measured at 24, 48, 72 hours using: 8.1. Treatment for local anaesthetic toxicity, defined as administration of intralipid therapy in the preceding 24-hour period 8.2. Bleeding or infection at the intervention insertion site 8.3. Catheter dislodgement requiring re-sited intervention in the preceding 24-hour period 9. Oxygen requirement measured as maximum flow rate of supplemental oxygen administered to participant immediately prior to receipt of trial intervention (defined as trial baseline), then at the following time points following receipt of intervention, 3, 6, 9, 12, 24 hours, 48 hours and 72 hours. 10. Condition-specific outcome measure measured using Outcomes after chest trauma score (OCTS) at baseline, 72 hours, 6 weeks 11. Pneumonia measured using drug chart/CRF defined as administration of antibiotics for community- or hospital-acqu | — |
Countries
England, United Kingdom
Outcome results
None listed