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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03919916
Other study ID # C&W19/007
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 28, 2021
Est. completion date June 10, 2022

Study information

Verified date May 2021
Source Chelsea and Westminster NHS Foundation Trust
Contact Robert J Pilling, MB ChB FRCA
Phone 02033158000
Email Robert.Pilling@chelwest.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 58
Est. completion date June 10, 2022
Est. primary completion date May 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Procedure:
Serratus plane block
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
Other:
Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine

Locations

Country Name City State
United Kingdom Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
Chelsea and Westminster NHS Foundation Trust St George's University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (35)

Battle CE, Hutchings H, Evans PA. Risk factors that predict mortality in patients with blunt chest wall trauma: a systematic review and meta-analysis. Injury. 2012 Jan;43(1):8-17. doi: 10.1016/j.injury.2011.01.004. Epub 2011 Jan 22. Review. — View Citation

Bayouth L, Safcsak K, Cheatham ML, Smith CP, Birrer KL, Promes JT. Early intravenous ibuprofen decreases narcotic requirement and length of stay after traumatic rib fracture. Am Surg. 2013 Nov;79(11):1207-12. — View Citation

Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. Review. — View Citation

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation

Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. — View Citation

Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. — View Citation

Cheema S, Richardson J, McGurgan P. Factors affecting the spread of bupivacaine in the adult thoracic paravertebral space. Anaesthesia. 2003 Jul;58(7):684-7. — View Citation

Clark GC, Schecter WP, Trunkey DD. Variables affecting outcome in blunt chest trauma: flail chest vs. pulmonary contusion. J Trauma. 1988 Mar;28(3):298-304. — View Citation

Cook TM, Counsell D, Wildsmith JA; Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Br J Anaesth. 2009 Feb;102(2):179-90. doi: 10.1093/bja/aen360. Epub 2009 Jan 12. — View Citation

Dehghan N, de Mestral C, McKee MD, Schemitsch EH, Nathens A. Flail chest injuries: a review of outcomes and treatment practices from the National Trauma Data Bank. J Trauma Acute Care Surg. 2014 Feb;76(2):462-8. doi: 10.1097/TA.0000000000000086. — View Citation

Dravid RM, Paul RE. Interpleural block - part 2. Anaesthesia. 2007 Nov;62(11):1143-53. Review. — View Citation

Duch P, Møller MH. Epidural analgesia in patients with traumatic rib fractures: a systematic review of randomised controlled trials. Acta Anaesthesiol Scand. 2015 Jul;59(6):698-709. doi: 10.1111/aas.12475. Epub 2015 Feb 13. Review. — View Citation

Durant E, Dixon B, Luftig J, Mantuani D, Herring A. Ultrasound-guided serratus plane block for ED rib fracture pain control. Am J Emerg Med. 2017 Jan;35(1):197.e3-197.e6. doi: 10.1016/j.ajem.2016.07.021. Epub 2016 Jul 19. — View Citation

Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007. — View Citation

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. — View Citation

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. — View Citation

Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. Review. — View Citation

Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31. — View Citation

Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21. — View Citation

Kunhabdulla NP, Agarwal A, Gaur A, Gautam SK, Gupta R, Agarwal A. Serratus anterior plane block for multiple rib fractures. Pain Physician. 2014 Jul-Aug;17(4):E553-5. — View Citation

Kunigo T, Murouchi T, Yamamoto S, Yamakage M. Injection Volume and Anesthetic Effect in Serratus Plane Block. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):737-740. doi: 10.1097/AAP.0000000000000649. — View Citation

Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topcu S. Chest injury due to blunt trauma. Eur J Cardiothorac Surg. 2003 Mar;23(3):374-8. — View Citation

López-Matamala B, Fajardo M, Estébanez-Montiel B, Blancas R, Alfaro P, Chana M. A new thoracic interfascial plane block as anesthesia for difficult weaning due to ribcage pain in critically ill patients. Med Intensiva. 2014 Oct;38(7):463-5. doi: 10.1016/j.medin.2013.10.005. Epub 2013 Nov 26. — View Citation

Mayes J, Davison E, Panahi P, Patten D, Eljelani F, Womack J, Varma M. An anatomical evaluation of the serratus anterior plane block. Anaesthesia. 2016 Sep;71(9):1064-9. doi: 10.1111/anae.13549. Epub 2016 Jul 20. — View Citation

Moore DC. Intercostal nerve block: spread of india ink injected to the rib's costal groove. Br J Anaesth. 1981 Apr;53(4):325-9. — View Citation

Naja ZM, El-Rajab M, Al-Tannir MA, Ziade FM, Tayara K, Younes F, Lönnqvist PA. Thoracic paravertebral block: influence of the number of injections. Reg Anesth Pain Med. 2006 May-Jun;31(3):196-201. — View Citation

Ochroch EA, Gottschalk A. Impact of acute pain and its management for thoracic surgical patients. Thorac Surg Clin. 2005 Feb;15(1):105-21. Review. — View Citation

Ökmen K, Ökmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26. — View Citation

Shanti CM, Carlin AM, Tyburski JG. Incidence of pneumothorax from intercostal nerve block for analgesia in rib fractures. J Trauma. 2001 Sep;51(3):536-9. — View Citation

Sirmali M, Türüt H, Topçu S, Gülhan E, Yazici U, Kaya S, Tastepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8. — View Citation

Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. — View Citation

Tighe SQ, Karmakar MK. Serratus plane block: do we need to learn another technique for thoracic wall blockade? Anaesthesia. 2013 Nov;68(11):1103-6. doi: 10.1111/anae.12423. Epub 2013 Sep 14. — View Citation

Working Party:; Association of Anaesthetists of Great Britain & Ireland; Obstetric Anaesthetists' Association; Regional Anaesthesia UK. Regional anaesthesia and patients with abnormalities of coagulation: the Association of Anaesthetists of Great Britain & Ireland The Obstetric Anaesthetists' Association Regional Anaesthesia UK. Anaesthesia. 2013 Sep;68(9):966-72. doi: 10.1111/anae.12359. Epub 2013 Aug 1. Erratum in: Anaesthesia. 2016 Mar;71(3):352. — View Citation

Yang Y, Young JB, Schermer CR, Utter GH. Use of ketorolac is associated with decreased pneumonia following rib fractures. Am J Surg. 2014 Apr;207(4):566-72. doi: 10.1016/j.amjsurg.2013.05.011. Epub 2013 Oct 7. — View Citation

Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9. — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Static visual analogue score (0-10) at 1 hour Defined as pain score at rest Measured at 1 hour
Secondary Dynamic visual analogue score (0-10) Defined as pain score on deep inspiration Measured at 1 hour, 24, 48 and 72 hours
Secondary Static visual analogue score (0-10) Defined as pain score at rest Measured at 24, 48 and 72 hours
Secondary Morphine consumption Amount of intravenous morphine consumed within each 24 hour period Measured at 24, 48 and 72 hours
Secondary Peak expiratory flow rate Calculated as a percentage of predicted Measured at 1, 24, 48 and 72 hours
Secondary 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
Secondary Incidence of hypotension Defined as a systolic blood pressure less than 90 mmHg Measured at 24, 48 and 72 hours
Secondary 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
Secondary Incidence of respiratory depression Defined as a respiratory rate of less than 12 breaths per minute Measured at 24, 48 and 72 hours
Secondary Occurence of pneumonia Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation. Within 30 days
Secondary Hospital length of stay Defined as the number of days the patient stayed in hospital Up to 6 months
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