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A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04863807
Recruitment Status : Completed
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

Brief Summary:
Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. However, TEA are often contraindicated due to other injuries or the use of anticoagulant medications, which also contraindicates other invasive nerve block techniques e.g. paravertebral catheters. A number of case reports have reported the safe use of alternative techniques such as Serratus Anterior Blocks (SAPB) and Erector Spinae Blocks (ESPB) and the anaesthesia community has taken them up widely based on this relatively limited evidence. In view of this, Womack et al recently published a large retrospective review examining the safety and efficacy of ultrasound guided paravertebral catheter analgesia techniques in rib fracture management along with small numbers of ESPBs. However, this data did not report the analgesic efficacy, patient reported pain relief or respiratory complications.The goal is to advance this body of evidence by reviewing our larger data set concerning the use of TEA and alternative regional techniques such as ESPB and SAPB. This comprehensive review will benefit patients by documenting the efficacy and safety of these techniques for clinicians managing rib fracture patients.

Condition or disease Intervention/treatment
Rib Fractures Pain, Acute Procedure: Regional Anaesthesia

Detailed Description:

Primary Objective The primary objective is to examine whether novel fascial plane blocks, e.g. SAPB and ESPB, are effective pain relief modalities in patients with rib fractures - the proportion of patients with a reduction in pain.

Secondary Objectives

The investigators review the safety profile and complications of TEA and alternative analgesic techniques such as ESPB and SAPB used for rib fracture management in our trauma centre. In particular the effects of regional anaesthesia techniques on:

  1. Opioid use
  2. Nausea & vomiting
  3. Respiratory complications
  4. Intubation & non-invasive ventilation (NIV)
  5. ICU admission for respiratory complications

The investigators will assess the duration of use and complication profile of regional anaesthetic techniques, including infection, analgesic failure and damage to other structures during insertion e.g. the lung.

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre Comparing Erector Spinae Plane Blocks, Serratus Anterior Plane Blocks and Epidurals
Actual Study Start Date : November 11, 2020
Actual Primary Completion Date : March 4, 2021
Actual Study Completion Date : March 30, 2021


Group/Cohort Intervention/treatment
Thoracic epidural for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare National Health Service (NHS) Trust 'Invasive rib fracture management pathway'
Procedure: Regional Anaesthesia
Thoracic epidural/Erector Spinae block/Serratus Anterior block

Erector Spinae block for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'
Procedure: Regional Anaesthesia
Thoracic epidural/Erector Spinae block/Serratus Anterior block

Serratus Anterior block for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'
Procedure: Regional Anaesthesia
Thoracic epidural/Erector Spinae block/Serratus Anterior block




Primary Outcome Measures :
  1. The proportion of patients with a reduction in pain [ Time Frame: 72 hours ]
    The investigators will review pain scores as recorded by clinical staff over 72 hours to assess pain relief efficacy, A verbal rating scale classifying pain as mild, moderate or severe is used at Imperial Data from the acute pain round records will also provide details regarding breathing comfort levels of the patient, coughing ability and deep inspiratory effort. These are recorded as yes/no answers and the team will assess the proportion of patients showing a reduction in pain scores.


Secondary Outcome Measures :
  1. Opioid Type [ Time Frame: 72 hours ]
    Data regarding type of opiate use

  2. Opioid mode of delivery [ Time Frame: 72 hours ]
    Mode of delivery of opioids

  3. Opioid use [ Time Frame: 72 hours ]
    Dosage requirement every 24 hours for a total of 72 hours

  4. Opioid complication(s) [ Time Frame: 72 hours ]
    Complications associated with opiates such as constipation, delirium and respiratory depression.

  5. Nausea and vomiting [ Time Frame: Time zero ]
    The incidence of nausea and vomiting pre-chest wall block

  6. NUmber of nausea and vomiting episodes [ Time Frame: 72 hours post block ]
    The incidence of nausea in the 72 hours post block will be recorded with the number of episodes

  7. Anti-emetic(s) used [ Time Frame: 72 hours post block ]
    The incidence of nausea in the 72 hours post block will be recorded with the number of anti-emetic medications required to treat.

  8. Lower respiratory tract infections [ Time Frame: Length of stay up 8 weeks ]
    Lower Respiratory Tract Infection (LRTI): for this study is defined as patients showing clinical features of chest infection including pyrexia (temperature >37.5°C), an increase in oxygen requirements from baseline, radiological evidence of chest infection or antimicrobial treatment of an LRTI started by the treating team.

  9. Respiratory complication(s) [ Time Frame: Length of stay up to 8 weeks ]
    Empyema/Parapneumonic effusions: defined as radiological evidence of fluid collections within the pleural space and therapeutic interventions required for treatment e.g. aspiration and drainage.

  10. Intensive care admission for respiratory complications [ Time Frame: Length of stay up to 8 weeks ]
    ICU admission for respiratory complications

  11. Intensive care admission [ Time Frame: Length of stay up to 8 weeks ]
    Number of patients requiring intubation and ventilation

  12. Intensive care mechanical ventilation [ Time Frame: Length of stay up to 8 weeks ]
    Number of days of mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years
  • Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway' (see Appendix A)
Criteria

Inclusion Criteria:

  • Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years
  • Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'

Exclusion Criteria:

  • Under 18 years old
  • Prisoners
  • Pregnant
  • Private patients
  • Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway'

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863807


Locations
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United Kingdom
Imperiial Collge Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Boyne Bellew Imperial College Healthcare NHS Trust
Publications of Results:

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04863807    
Other Study ID Numbers: 19SM5668
276933 ( Other Identifier: HRA and Health and Care Research Wales (HCRW) )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
epidural
erector spinae block
serratus anterior block
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Rib Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Thoracic Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs