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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
David
Hewson
+44 7778 178639
david.hewson@nottingham.ac.uk
Mrs
Harriet
Howard
+44 7812 268374
Harriet.Howard2@nuh.nhs.uk
Erector spinae plane blocks for the early analgesia of rib fractures in trauma
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
We don't have a perfect way to give people pain relief for broken ribs, but doctors try combinations of tablets, strong painkillers in the a drip, epidural injections and even surgery to help. Physiotherapy and careful nursing care is 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 having 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36130745/ (added 22/09/2022)
You can take part if:
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 un
You may not be able to take part if:
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 50kg or less thereby precluding safe dosing of local anaesthetic for ESP block.6. Current or recent involvement in other clinical research.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Harriet
Howard
+44 7812 268374
Harriet.Howard2@nuh.nhs.uk
Dr
David
Hewson
+44 7778 178639
david.hewson@nottingham.ac.uk
The study is sponsored by Nottingham University Hospitals NHS Trust and funded by NIHR Central Commissioning Facility (CCF); National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 51544
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