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

NCT03919916 | Unknown

• 1 other identifier: C&W19/007
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Static visual analogue score (0-10) at 1 hour

  Defined as pain score at rest

  Measured at 1 hour

Secondary Outcomes (10)

• Dynamic visual analogue score (0-10)

  Measured at 1 hour, 24, 48 and 72 hours

• Static visual analogue score (0-10)

  Measured at 24, 48 and 72 hours

• Morphine consumption

  Measured at 24, 48 and 72 hours

• Peak expiratory flow rate

  Measured at 1, 24, 48 and 72 hours

• Level of sedation

  Measured at 24, 48 and 72 hours

Study Arms (2)

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

Procedure: Serratus plane block; Other: Patient controlled analgesia

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

Other: Patient controlled analgesia

Interventions

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

Also known as: Experimental

Serratus plane block and patient controlled analgesia

Patient controlled analgesia OTHER

Computerised pump device facilitating the patient self administration and titration as needed of morphine

Also known as: Active comparator

Patient controlled analgesia only; Serratus plane block and patient controlled analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Isolated chest trauma
• Two or more unilateral rib fractures

You may not qualify if:

• 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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• St George's University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

RECRUITING

Related Publications (35)

• 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.

  PMID: 7996614 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.

  PMID: 16269301 BACKGROUND

• Sirmali M, Turut H, Topcu S, Gulhan 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. doi: 10.1016/s1010-7940(03)00256-2.

  PMID: 12853057 BACKGROUND

• Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097/00005373-200006000-00007.

  PMID: 10866248 BACKGROUND

• 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.

  PMID: 23592156 BACKGROUND

• 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.

  PMID: 24612969 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.2004.52223.x.

  PMID: 15086666 BACKGROUND

• 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.

  PMID: 21256488 BACKGROUND

• 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. doi: 10.1016/s1010-7940(02)00813-8.

  PMID: 12614809 BACKGROUND

• 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. doi: 10.1097/00005373-198803000-00004.

  PMID: 3351988 BACKGROUND

• 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.

  PMID: 24458051 BACKGROUND

• 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. doi: 10.1097/TA.0000000000001209.

  PMID: 27533913 BACKGROUND

• 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.

  PMID: 24165259 BACKGROUND

• 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.

  PMID: 24112670 BACKGROUND

• 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.

  PMID: 18443635 BACKGROUND

• Duch P, Moller 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.

  PMID: 25683770 BACKGROUND

• Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30. doi: 10.1016/j.surg.2004.05.019.

  PMID: 15300210 BACKGROUND

• 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.

  PMID: 19139027 BACKGROUND

• 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. doi: 10.1093/bja/53.4.325.

  PMID: 7225265 BACKGROUND

• 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. doi: 10.1046/j.1365-2044.2003.03189_1.x.

  PMID: 12886912 BACKGROUND

• Naja ZM, El-Rajab M, Al-Tannir MA, Ziade FM, Tayara K, Younes F, Lonnqvist PA. Thoracic paravertebral block: influence of the number of injections. Reg Anesth Pain Med. 2006 May-Jun;31(3):196-201. doi: 10.1016/j.rapm.2005.12.004.

  PMID: 16701182 BACKGROUND

• 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. doi: 10.1097/00005373-200109000-00019.

  PMID: 11535906 BACKGROUND

• Dravid RM, Paul RE. Interpleural block - part 2. Anaesthesia. 2007 Nov;62(11):1143-53. doi: 10.1111/j.1365-2044.2007.05181.x.

  PMID: 17924896 BACKGROUND

• 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. No abstract available.

  PMID: 24032664 BACKGROUND

• 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.

  PMID: 23923989 BACKGROUND

• 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.

  PMID: 28891826 BACKGROUND

• 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.

  PMID: 27440171 BACKGROUND

• 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.

  PMID: 23905877 BACKGROUND

• Ochroch EA, Gottschalk A. Impact of acute pain and its management for thoracic surgical patients. Thorac Surg Clin. 2005 Feb;15(1):105-21. doi: 10.1016/j.thorsurg.2004.08.004.

  PMID: 15707349 BACKGROUND

• Okmen K, Okmen 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.

  PMID: 28447227 BACKGROUND

• 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.

  PMID: 27939192 BACKGROUND

• Lopez-Matamala B, Fajardo M, Estebanez-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. No abstract available.

  PMID: 24289954 BACKGROUND

• 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. No abstract available.

  PMID: 25054407 BACKGROUND

• 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. No abstract available.

  PMID: 27595172 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.

  PMID: 28291768 BACKGROUND

MeSH Terms

Conditions

Thoracic Injuries; Rib Fractures; Agnosia; Pain

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Damon Foster

  Chelsea and Westminster NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Robert J Pilling, MB ChB FRCA

CONTACT

02033158000; Robert.Pilling@chelwest.nhs.uk

Damon Foster

CONTACT

02033156825; damon.foster1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 18, 2019
• Study Start: May 28, 2021
• Primary Completion: May 10, 2022
• Study Completion: June 10, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)