AnesthesiaSABRENCT03711812
Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
A study testing Serratus Anterior Plane Catheter and Thoracic Epidural Catheter in people with Anesthesia and Rib Fractures, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Rib Fractures
- What is being tested?
- Serratus Anterior Plane Catheter and Thoracic Epidural Catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years suffering 2 or more rib fractures
Who cannot join
- Significant renal dysfunction (baseline creatinine >150μmol/l - morphine contra- indicated)
- Pregnancy
- Patients with chronic pain on regular analgesic medication
- Patients with significant coagulation abnormality (unsafe to site blocks)
- Participation in another interventional study that will interact with this trial.
- Patients unable to give informed consent
Show all 9Show fewer
- Hypersensitivity to local anaesthetic (or any other study drug).
- Contraindication to NSAID (peptic ulceration or sensitive asthma)
- Weight <50kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SABRE: Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures.
Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days.
Read more
Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable.
The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment.
The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.
- Conditions
- Anesthesia, Rib Fractures
- Being tested
- Serratus Anterior Plane Catheter, Thoracic Epidural Catheter
- Keywords
- regional anaesthesia, rib fractures
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane CatheterProcedure or surgery
Insertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion
Thoracic Epidural CatheterProcedure or surgery
Insertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion
| Study group | Role | What they receive |
|---|---|---|
| Serratus Anterior Plane Catheter | Active comparator | Not described Receives: Procedure: Serratus Anterior Plane Catheter |
| Thoracic Epidural | Placebo comparator | Not described Receives: Procedure: Thoracic Epidural Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous morphine use via a patient controlled pump
This will be measured as the total amount (in milligrams) of intravenous morphine used via a patient controlled pump in 72 hours.
Measured: 72 hours
Secondary outcomes (4)
static and dynamic pain scores measurements
This will be measured using a visual analogue scale from 0(no pain) to 10(unbearable pain). The measurement will be done whilst the patient is at rest and again on movement.
Measured: 72 hours
side effects/ complications of interventions
The side effects and complications of either a thoracic epidural or serratus anterior plane block will be recorded. This includes failure to establish the block and/or catheter, decreased blood pressure, neurological sequelae, nausea and vomiting and itching.
Measured: 72 hours
spirometry
Spirometry will be undertaken at the bedside and the tidal volumes will be recorded 3 times and the average taken of the 3 measurements.
Measured: 72 hours
quality of recovery assessment
The quality of recovery (QoR) will be assessed using the QoR40. The QoR-40 is a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start5 Nov 2018
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711812
- Sponsor's protocol ID
- 232220
- Acronym
- SABRE
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2018
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SABRE: Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
- ClinicalTrials.gov ID
- NCT03711812
- Acronym / sponsor ID
- SABRE / 232220
- Conditions
- Anesthesia, Rib Fractures
- Keywords
- regional anaesthesia, rib fractures
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Covid-19
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures.
Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days.
Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable.
The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment.
The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Anterior Plane Catheter | Active comparator | Procedure: Serratus Anterior Plane Catheter |
| Thoracic Epidural | Placebo comparator | Procedure: Thoracic Epidural Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged over 18 years suffering 2 or more rib fractures
Key exclusion criteria (9 listed)
- Significant renal dysfunction (baseline creatinine >150μmol/l - morphine contra- indicated)
- Pregnancy
- Patients with chronic pain on regular analgesic medication
- Patients with significant coagulation abnormality (unsafe to site blocks)
- Participation in another interventional study that will interact with this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus Anterior Plane CatheterInsertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion | Procedure or surgery | Serratus Anterior Plane Catheter |
| Thoracic Epidural CatheterInsertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion | Procedure or surgery | Thoracic Epidural |
Primary outcome
intravenous morphine use via a patient controlled pump
Time frame: 72 hours
This will be measured as the total amount (in milligrams) of intravenous morphine used via a patient controlled pump in 72 hours.
4 secondary outcomes
static and dynamic pain scores measurements
Time frame: 72 hours
side effects/ complications of interventions
Time frame: 72 hours
spirometry
Time frame: 72 hours
quality of recovery assessment
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Anterior Plane Catheter and Thoracic Epidural Catheter in people with Anesthesia and Rib Fractures, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous morphine use via a patient controlled pump (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.