Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures

Study Overview
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Brief Summary
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In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Our primary outcome is the static visual analogue scale score at one hour.

Detailed Description
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Rib breaks, or fractures, can cause pain that can be very difficult to manage and can result in chest infection and death. Such pain can be managed with either systemic drugs like morphine, which are given by mouth or through the veins, or local anaesthetic techniques, which can numb the painful area. Use of systemic drugs is however limited by significant side effects and traditional local anaesthetic techniques have problems of their own. Epidural analgesia, where local anaesthetic is placed near the spine, can only be done by those with a high level of technical skill and cannot be performed in patients with spine injuries, positioning difficulties and clotting problems. Complications and side effects can be common and/or serious and include failure, fall in blood pressure, and nerve and spinal cord damage. More recently, there has been interest in a new local anaesthetic technique, serratus plane block. Serratus plane block is simple to learn and can be done without any need for repositioning of the patient. It avoids some of the complications and side effects related to other local anaesthetic techniques and is more easily looked after by nursing staff on the ward. In view of this, we are aiming to recruit 44 adults with isolated chest injury and two or more rib fractures on one side. Each patient will either receive a serratus plane block in conjunction with morphine through the veins or just morphine alone. Our main aim is to assess how bad the pain is at 1 hour, but we will also compare the pain score, morphine consumption, lung function, level of sleepiness, and the frequency of low blood pressure, nausea and vomiting and slow breathing over the first 72 hours, as well as the hospital length of stay and occurrence of lung infection within 30 days.

Official Title
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Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs

Conditions
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Thoracic Injuries, Rib Fractures, Anaesthesia, Local, Levobupivacaine, Analgesia, Patient-Controlled, Pain

Intervention / Treatment
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* Procedure: Serratus plane block
* Other: Patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Isolated chest trauma Two or more unilateral rib fractures Exclusion Criteria: One unilateral rib fracture Bilateral rib fractures Flail chest Clavicular fractures Polytrauma Sternal fracture or injury Thoracic spine injury GCS less than 15 Acute or chronic confusional state Delirium or psychiatric illness Chronic lung disease necessitating home nebulisers and/or oxygen Coagulopathy, defined as a platelet count less than 100 x 109/l , PT >15 or APTT >38 End stage liver disease Severe congestive cardiac failure Significant renal failure, defined as a creatinine >150µmol/l Local infection at potential site of SBP insertion Pregnancy or breastfeeding History of chronic pain or opioid dependence Current chronic analgesic therapy, not to include paracetamol, NSAIDs and/or codeine Requirement for tracheal intubation and mechanical ventilation Allergy to local anaesthetics and/or opioids Inability to control and self-administer opioids with PCA due to confusion, learning difficulties or poor manual dexterity Unable to speak and/or understand English Patients known to clinicians to be COVID-19 positive as determined by PCR or for whom there is a clinical suspicion that they might be COVID-19 positive will be excluded from the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus plane block and patient controlled analgesia<br>Initial local anaesthetic bolus of 0.4 ml/kg of 0.25% levobupivacaine. Subsequent continuous local anaesthetic infusion of 0.125% levobupivacaine Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes | Procedure: Serratus plane block<br>* Placement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib<br>* Other names: Experimental;Other: Patient controlled analgesia<br>* Computerised pump device facilitating the patient self administration and titration as needed of morphine<br>* Other names: Active comparator;|
| Active Comparator: Patient controlled analgesia only<br>Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes | Other: Patient controlled analgesia<br>* Computerised pump device facilitating the patient self administration and titration as needed of morphine<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static visual analogue score (0-10) at 1 hour | Defined as pain score at rest | Measured at 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic visual analogue score (0-10) | Defined as pain score on deep inspiration | Measured at 1 hour, 24, 48 and 72 hours | 
| Static visual analogue score (0-10) | Defined as pain score at rest | Measured at 24, 48 and 72 hours | 
| Morphine consumption | Amount of intravenous morphine consumed within each 24 hour period | Measured at 24, 48 and 72 hours | 
| Peak expiratory flow rate | Calculated as a percentage of predicted | Measured at 1, 24, 48 and 72 hours | 
| Level of sedation | Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome | Measured at 24, 48 and 72 hours | 
| Incidence of hypotension | Defined as a systolic blood pressure less than 90 mmHg | Measured at 24, 48 and 72 hours | 
| Incidence of nausea and vomiting | Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome | Measured at 24, 48 and 72 hours | 
| Incidence of respiratory depression | Defined as a respiratory rate of less than 12 breaths per minute | Measured at 24, 48 and 72 hours | 
| Occurence of pneumonia | Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation. | Within 30 days | 
| Hospital length of stay | Defined as the number of days the patient stayed in hospital | Up to 6 months |