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出境医 / 临床实验 / Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures (COPE)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Thoracic Injuries Rib Fractures Anaesthesia, Local Levobupivacaine Analgesia, Patient-Controlled Pain Procedure: Serratus plane block Other: Patient controlled analgesia Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : May 10, 2022
Estimated Study Completion Date : June 10, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Serratus plane block and 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

 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 Name: Experimental

Other: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Other Name: Active comparator
Active Comparator: Patient controlled analgesia only
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
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Other Name: Active comparator
Outcome Measures
Primary Outcome Measures :
  1. Static visual analogue score (0-10) at 1 hour [ Time Frame: Measured at 1 hour ]
    Defined as pain score at rest


Secondary Outcome Measures :
  1. Dynamic visual analogue score (0-10) [ Time Frame: Measured at 1 hour, 24, 48 and 72 hours ]
    Defined as pain score on deep inspiration

  2. Static visual analogue score (0-10) [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as pain score at rest

  3. Morphine consumption [ Time Frame: Measured at 24, 48 and 72 hours ]
    Amount of intravenous morphine consumed within each 24 hour period

  4. Peak expiratory flow rate [ Time Frame: Measured at 1, 24, 48 and 72 hours ]
    Calculated as a percentage of predicted

  5. Level of sedation [ Time Frame: 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

  6. Incidence of hypotension [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a systolic blood pressure less than 90 mmHg

  7. Incidence of nausea and vomiting [ Time Frame: Measured at 24, 48 and 72 hours ]
    Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome

  8. Incidence of respiratory depression [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a respiratory rate of less than 12 breaths per minute

  9. Occurence of pneumonia [ Time Frame: Within 30 days ]
    Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.

  10. Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Robert J Pilling, MB ChB FRCA 02033158000 ext 58026 Robert.Pilling@chelwest.nhs.uk
Contact: Damon Foster 02033156825 ext 58026 damon.foster1@nhs.net

Locations
Layout table for location information
United Kingdom
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    chelwest.research@nhs.net   
Contact: Robert Pilling, MB ChB FRCA       robert.pilling1@nhs.net   
Principal Investigator: Robert Pilling, MB ChB FRCA         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
Investigators
Layout table for investigator information
Study Chair: Damon Foster Chelsea and Westminster Hospital NHS Foundation Trust
Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE May 28, 2021
Estimated Primary Completion Date May 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		Static visual analogue score (0-10) at 1 hour [ Time Frame: Measured at 1 hour ]
Defined as pain score at rest
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2021)
  • Dynamic visual analogue score (0-10) [ Time Frame: Measured at 1 hour, 24, 48 and 72 hours ]
    Defined as pain score on deep inspiration
  • Static visual analogue score (0-10) [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as pain score at rest
  • Morphine consumption [ Time Frame: Measured at 24, 48 and 72 hours ]
    Amount of intravenous morphine consumed within each 24 hour period
  • Peak expiratory flow rate [ Time Frame: Measured at 1, 24, 48 and 72 hours ]
    Calculated as a percentage of predicted
  • Level of sedation [ Time Frame: 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
  • Incidence of hypotension [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a systolic blood pressure less than 90 mmHg
  • Incidence of nausea and vomiting [ Time Frame: Measured at 24, 48 and 72 hours ]
    Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
  • Incidence of respiratory depression [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a respiratory rate of less than 12 breaths per minute
  • Occurence of pneumonia [ Time Frame: Within 30 days ]
    Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.
  • Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Dynamic visual analogue score (0-10) [ Time Frame: Measured at 1 hour, 24, 48 and 72 hours ]
    Defined as pain score on deep inspiration
  • Static visual analogue score (0-10) [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as pain score at rest
  • Morphine consumption [ Time Frame: Measured at 24, 48 and 72 hours ]
    Amount of intravenous morphine consumed within each 24 hour period
  • Peak expiratory flow rate [ Time Frame: Measured at 1, 24, 48 and 72 hours ]
    Calculated as a percentage of predicted
  • Level of sedation [ Time Frame: 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
  • Incidence of hypotension [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a systolic blood pressure less than 90 mmHg
  • Incidence of nausea and vomiting [ Time Frame: Measured at 24, 48 and 72 hours ]
    Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
  • Incidence of respiratory depression [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a respiratory rate of less than 12 breaths per minute
  • Occurence of pneumonia [ Time Frame: Within 30 days ]
  • Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures
Official Title  ICMJE Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thoracic Injuries
  • Rib Fractures
  • Anaesthesia, Local
  • Levobupivacaine
  • Analgesia, Patient-Controlled
  • Pain
Intervention  ICMJE
  • 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 Name: Experimental
  • Other: Patient controlled analgesia
    Computerised pump device facilitating the patient self administration and titration as needed of morphine
    Other Name: Active comparator
Study Arms  ICMJE
  • Experimental: Serratus plane block and 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

    Interventions:
    • Procedure: Serratus plane block
    • Other: Patient controlled analgesia
  • Active Comparator: Patient controlled analgesia only
    Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
    Intervention: Other: Patient controlled analgesia
Publications *
  • Ziegler DW, Agarwal NN. The morbidity and mortality of rib fractures. J Trauma. 1994 Dec;37(6):975-9.
  • 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.
  • Sirmali M, Türüt H, Topçu S, Gülhan E, Yazici U, Kaya S, Taştepe I. A comprehensive analysis of traumatic rib fractures: morbidity, mortality and management. Eur J Cardiothorac Surg. 2003 Jul;24(1):133-8.
  • Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Bulger EM, Edwards T, Klotz P, Jurkovich GJ. Epidural analgesia improves outcome after multiple rib fractures. Surgery. 2004 Aug;136(2):426-30.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Dravid RM, Paul RE. Interpleural block - part 2. Anaesthesia. 2007 Nov;62(11):1143-53. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 10, 2022
Estimated Primary Completion Date May 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robert J Pilling, MB ChB FRCA 02033158000 ext 58026 Robert.Pilling@chelwest.nhs.uk
Contact: Damon Foster 02033156825 ext 58026 damon.foster1@nhs.net
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919916
Other Study ID Numbers  ICMJE C&W19/007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chelsea and Westminster NHS Foundation Trust
Study Sponsor  ICMJE Chelsea and Westminster NHS Foundation Trust
Collaborators  ICMJE St George's University Hospitals NHS Foundation Trust
Investigators  ICMJE
Study Chair: Damon Foster Chelsea and Westminster Hospital NHS Foundation Trust
PRS Account Chelsea and Westminster NHS Foundation Trust
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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