Advanced pain relief for rib fractures following trauma: a multicentre trial with patients allocated to either treatment or placebo looking at possibility of a larger scale study
| ISRCTN | ISRCTN49307616 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49307616 |
| IRAS number | 299011 |
| Secondary identifying numbers | CPMS 51544, NIHR202195, IRAS 299011 |
- Submission date
- 01/03/2022
- Registration date
- 09/03/2022
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
We don't have a perfect way to give people pain relief for broken ribs, but doctors try combinations of tablets, strong painkillers in a drip, epidural injections and even surgery to help. Physiotherapy and careful nursing care are also really important to help people recover. But there is no perfect pain relief 'recipe' that works for every person every time.
The purpose of this study is to test if a new method of pain relief - called an erector spinae plane (ESP) block - can help people with broken ribs get better pain relief and reduce their risk of getting chest problems as a result of their broken ribs. ESP blocks are injections, like an epidural, that are simple to do and suitable for almost everyone. We know they help people after operations but we don't know if they can help with broken ribs. An ESP block involves injecting local anaesthetic into the back to numb nerves which supply the broken ribs. We want to know if performing an ESP block soon after someone has broken their ribs can improve their health during their hospital admission, specifically the pain they suffer and their risk of needing extra oxygen or developing a chest infection.
To test ESP blocks properly, we need to do a large clinical trial at lots of hospitals that care for people with broken ribs. Before we launch into such a big project, it is important to 'test the water' and make sure we design that trial properly and understand what problems we might encounter. This is called a feasibility study and is what is being proposed here.
This feasibility study will run at three UK hospitals in Nottingham, Manchester, and London, caring for people with broken ribs. We will see if adding an ESP block to the existing 'recipes' for pain relief for broken ribs makes a difference to 50 people's pain relief and risk of becoming more unwell. We will collect data (for example, pain scores) and do interviews (with patients and local researchers), which will help us design a well-thought-out large trial. If this feasibility study works, we will ask for NHS support for a larger trial within 12 months of finishing this project.
Who can participate?
Patients aged 18 years and older who are a new admission to a major trauma centre with rib fracture
What does the study involve?
This study is called a randomised controlled trial because we need to compare different treatments between groups of patients. To try and make sure the groups are the same to start with, each patient is put into a group by chance (randomly). The results are then compared. In this trial, there are two groups: people who receive an ESP block alongside other pain relief, and people who receive a placebo, or “dummy” ESP block alongside other pain relief.
What are the possible benefits and risks of participating?
There is no guarantee that taking part in the research will benefit you; however, you will be helping us understand this injury better and potentially improve care for patients in the future.
Common risks of ESP blocks are bleeding, infection or the injection needing to be repeated. A rare complication can be local anaesthetic toxicity. You will be closely monitored for all possible side effects.
Where is the study run from?
Nottingham University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2021 to March 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Harriet Howard, Harriet.Howard2@nuh.nhs.uk
Contact information
Scientific
Research and Innovation
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 7812 268374 |
|---|---|
| Harriet.Howard2@nuh.nhs.uk |
Principal Investigator
Department of Anaesthesia and Critical Care
Queens Medical Centre
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 7778 178639 |
|---|---|
| david.hewson@nottingham.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41262 PIS_v2.0_25Jan2022.pdf |
| Scientific title | Erector Spinae Plane blocks for the Early Analgesia of Rib fractures in trauma: a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| Study acronym | ESPEAR |
| Study hypothesis | To determine feasibility of progression to a definitive RCT. |
| Ethics approval(s) | Approved 22/02/2022, South Central - Oxford B Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8270; oxfordb.rec@hra.nhs.uk), ref: 22/SC/005 |
| Condition | Erector spinae plane blocks for the early analgesia of rib fractures in trauma |
| Intervention | 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 fractures. Other than the allocated intervention, both groups will be followed up in the same way to exclude bias beyond procedures necessary for the allocation of treatment. Randomisation will be to two groups: 1. ESP block plus multimodal analgesia (intervention) 2. Sham (or 'dummy') ESP block plus multimodal analgesia (control) Participants randomised to ESP block plus multimodal analgesia (intervention) will receive an US-guided ESP block. An initial injection of 30ml of 0.25% levo-bupivacaine will be placed, followed by catheter programmed-intermittent boluses of 15ml 0.125% levo-bupivacaine given 3 hourly with option for patient or clinician top up of 5 ml up to every 1 hour. This is in keeping with the product license of levo-bupivacaine. Participants allocated to the intervention will additionally receive standard supportive care and multimodal analgesia according to British Orthopaedic Association 2016 guidelines. The site-specific adoption of multimodal analgesia regimes will be reviewed as part of the site feasibility. Sham Group: Participants randomised to Sham ESP block plus multimodal analgesia (control) will receive a sham (also known as a 'dummy') ultrasound-guided ESP block in a sitting or lateral decubitus position determined by optimal patient comfort. The sham block will target the vertebral transverse process corresponding to the mid-point of the consecutively fractured ribs on the side of moderate or severe unilateral pain. A single 1 ml subcutaneous injection will be made and a perineural catheter applied and affixed by skin-glue externally on the skin, which will be dressed and connected to an infusion pump with a patient-button, which will remain turned off. Participants allocated to the comparator will additionally receive standard supportive care and multimodal analgesia according to individual study site protocol as per the intervention arm. Qualitative research will be embedded within the ESPEAR RCT feasibility study to provide insights into the feasibility and design of a main RCT trial. It will focus on two key aspects: 1. Understanding the acceptability and feasibility of delivering the intervention/control in practice 2. Exploring patients’ experience of trial participation and acceptability of interventions |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Any long acting local anaesthetic |
| Primary outcome measure | 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 outcome measures | 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-acquired pneumonia assessed in the 24 hours prior to receipt of trial intervention (defined as trial baseline), then at the following time points at baseline, 24, 48, 72 hours, and 6 weeks 12. Escalation to critical care measured using local hospital system at baseline, 24, 48, 72 hours, and 6 weeks 13. Length of hospital stay measured using local hospital system at 6 weeks 14. Quality of life (EQ-5D-5L) at baseline, 24, 48, 72 hours, 6 weeks 15. Mortality measured using local hospital system/GP contact at 6 weeks 16. Review/Reporting of AEs/SAEs – all AEs/SAEs will be logged at the trial coordinating centre (Nottingham) at 12, 24, 48, 72 hours, and 6 weeks |
| Overall study start date | 01/05/2021 |
| Overall study end date | 13/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50 |
| Total final enrolment | 27 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/07/2022 |
| Recruitment end date | 31/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Nottingham
NG7 2UH
United Kingdom
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Phone | +44 1159709049 |
|---|---|
| ResearchSponsor@nuh.nhs.uk | |
| Website | http://www.nuh.nhs.uk/ |
"ROR" |
https://ror.org/05y3qh794 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request from Dr David Hewson (david.hewson@nottingham.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 25/01/2022 | 08/03/2022 | No | Yes |
| Participant information sheet | Participant information sheet summary version 1.2 |
21/02/2022 | 08/03/2022 | No | Yes |
| Protocol article | 21/09/2022 | 22/09/2022 | Yes | No | |
| Plain English results | 24/06/2025 | No | Yes |
Additional files
- 41262 PIS_v2.0_25Jan2022.pdf
- 41262 PIS_Summary_v1.2_21Feb2022.pdf
- Participant information sheet summary
- ISRCTN49307616_PlainEnglishResults.pdf
Editorial Notes
24/06/2025: Plain English results uploaded.
26/03/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/03/2024 to 31/01/2024.
2. The overall study end date was changed from 12/05/2024 to 13/03/2024.
3. Total final enrolment added.
10/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2024 to 31/03/2024.
2. The overall study end date was changed from 13/03/2024 to 12/05/2024.
28/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/10/2023 to 31/01/2024.
2. The overall end date was changed from 01/10/2024 to 13/03/2024.
3. The study participating centres were added.
4. The plain English summary was updated to reflect these changes.
05/10/2023: The following changes were made to the trial record:
1. The drug name was changed from "levo-bupivacaine" to "any long acting local anaesthetic".
2. The inclusion criteria were changed.
3. The exclusion criteria were changed.
22/09/2022: Publication reference added.
07/06/2022: The recruitment start date was changed from 01/04/2022 to 01/07/2022.
01/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
