Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures
- Conditions
- Thoracic InjuriesAnaesthesia, LocalLevobupivacaineAnalgesia, Patient-ControlledRib FracturesPain
- Interventions
- Procedure: Serratus plane blockOther: Patient controlled analgesia
- Registration Number
- NCT03919916
- Lead Sponsor
- Chelsea and Westminster NHS Foundation Trust
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 58
- 18 years of age or older
- Isolated chest trauma
- Two or more unilateral rib fractures
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serratus plane block and patient controlled analgesia Patient controlled analgesia 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 Serratus plane block and patient controlled analgesia Serratus plane block 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 Patient controlled analgesia only Patient controlled analgesia Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
- Primary Outcome Measures
Name Time Method Static visual analogue score (0-10) at 1 hour Measured at 1 hour Defined as pain score at rest
- Secondary Outcome Measures
Name Time Method Dynamic visual analogue score (0-10) Measured at 1 hour, 24, 48 and 72 hours Defined as pain score on deep inspiration
Static visual analogue score (0-10) Measured at 24, 48 and 72 hours Defined as pain score at rest
Morphine consumption Measured at 24, 48 and 72 hours Amount of intravenous morphine consumed within each 24 hour period
Incidence of hypotension Measured at 24, 48 and 72 hours Defined as a systolic blood pressure less than 90 mmHg
Incidence of respiratory depression Measured at 24, 48 and 72 hours Defined as a respiratory rate of less than 12 breaths per minute
Hospital length of stay Up to 6 months Defined as the number of days the patient stayed in hospital
Incidence of nausea and vomiting Measured at 24, 48 and 72 hours Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
Peak expiratory flow rate Measured at 1, 24, 48 and 72 hours Calculated as a percentage of predicted
Level of sedation Measured at 24, 48 and 72 hours Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome
Occurence of pneumonia Within 30 days Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.
Trial Locations
- Locations (1)
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, United Kingdom