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| Name | Class |
|---|---|
| St George's University Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus plane block and patient controlled analgesia | Experimental | 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 | Active Comparator | Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus plane block | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Static visual analogue score (0-10) at 1 hour | Defined as pain score at rest | Measured at 1 hour |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert J Pilling, MB ChB FRCA | Contact | 02033158000 | 58026 | Robert.Pilling@chelwest.nhs.uk |
| Damon Foster | Contact | 02033156825 | 58026 | damon.foster1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Damon Foster | Chelsea and Westminster NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust | Recruiting | London | SW10 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7996614 | Background | Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. doi: 10.1097/00005373-199412000-00018. | |
| 16269301 | Background | Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016/j.surg.2005.07.022. |
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|
| Patient controlled analgesia | Other | Computerised pump device facilitating the patient self administration and titration as needed of morphine |
|
|
| 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 |
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| 28291768 | Background | Fu P, Weyker PD, Webb CA. Case Report of Serratus Plane Catheter for Pain Management in a Patient With Multiple Rib Fractures and an Inferior Scapular Fracture. A A Case Rep. 2017 Mar 15;8(6):132-135. doi: 10.1213/XAA.0000000000000431. |
| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D012253 | Rib Fractures |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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