The ESPEAR Trial
Research type
Research Study
Full 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.
IRAS ID
299011
Contact name
David Hewson
Contact email
Sponsor organisation
Nottingham University Hospital
ISRCTN Number
ISRCTN49307616
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
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.\nThe 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.\nTo 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. 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. \n
Lay summary of study results: Erector Spinae Plane blocks for the Early Analgesia of Rib fractures in trauma (ESPEAR): a multicentre feasibility randomised trial.
The ESPEAR study would like to thank the participants who took part in this research.
Background
Rib fractures caused by trauma cause significant pain.
Patients risk several serious issues, including:
• Hypoventilation: Breathing too slowly or shallowly, which limits oxygen intake.
• Atelectasis: This is when a lung collapses.
• Hypoxia: The body lacks enough oxygen for normal functions.
• Retained secretions: Mucus builds up in the lungs.
• Pneumonia: An inflammation of the lungs.
• Respiratory failure: Breathing may stop altogether.
• Death: The most severe outcome.
These conditions can arise if not monitored closely.
Effective pain relief is thought to improve these outcomes. Patients receive various types of pain relief. These include oral (by mouth), intravenous (through a vein), and epidural (injection near the spinal cord). The Erector spinae place (ESP) blockade is a new pain relief method. It may work, but more research in a clinical trial is needed.
Methods
We conducted a multicentre, randomised controlled pilot study. This study aimed to see if a final clinical trial of ESP block and catheter for rib fractures is possible. It was a small study to check if we could run a larger one. Adults with rib fractures were randomised to either ESP blockade and catheter, or placebo ESP blockade and catheter. All participants also had other pain relief. Participants and outcome assessors did not know what treatment was given.
The trial focused on three main points:
• Recruitment rate, aiming for 1.11 participants per site each month.
• Retention rate, with a target of 80% or higher for participants staying in the study.
• The ease of running the trial.
This was found by staff interview.Results
Twenty-five participants joined this study. Their average age was 57 years, and they had on average 5 rib fractures each. The participants were recruited from three major trauma centres in the UK. Each centre brought in 0.69 participants per month. At the 6-week follow-up, 80% of participants stayed in the study. They did not withdraw or get lost to follow-up. Recruitment was lower than expected. This shows that the current study design isn’t practical for a larger trial.
For future research, we suggest key changes in: (i) the intervention, (ii) bias reduction methods, and (iii) the timing and type of outcome measures.
Conclusion
A final study to check how well erector spinae plane blockade works for pain relief after blunt force chest injuries needs major changes. An open-label study will look at single-shot ESP blockade. It will use patient-reported pain intensity in the first 24 hours as the main outcome. This may provide helpful insights. This should take place at sites where ESP blocks are already used to address the issues faced in this studyREC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0005
Date of REC Opinion
23 Feb 2022
REC opinion
Further Information Favourable Opinion