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

• ClinicalTrials.gov Identifier: NCT04863807
• Recruitment Status: Completed
• First Posted: April 28, 2021
• Last Update Posted: April 28, 2021
• Sponsor: Imperial College Healthcare NHS Trust
• Information provided by (Responsible Party): Imperial College Healthcare NHS Trust

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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'

Contacts and Locations

Locations

United Kingdom

Imperiial Collge Healthcare NHS Trust

London, United Kingdom, W2 1NY

Sponsors and Collaborators

Imperial College Healthcare NHS Trust

Investigators

• Principal Investigator: Boyne Bellew; Imperial College Healthcare NHS Trust

More Information

Publications of Results:

Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67.

Ahn Y, Görlinger K, Alam HB, Eikermann M. Pain-associated respiratory failure in chest trauma. Anesthesiology. 2013 Mar;118(3):701-8. doi: 10.1097/ALN.0b013e318283996b.

Barnea Y, Kashtan H, Skornick Y, Werbin N. Isolated rib fractures in elderly patients: mortality and morbidity. Can J Surg. 2002 Feb;45(1):43-6.

Jones KM, Reed RL 2nd, Luchette FA. The ribs or not the ribs: which influences mortality? Am J Surg. 2011 Nov;202(5):598-604. doi: 10.1016/j.amjsurg.2010.09.029. Epub 2011 Aug 26.

Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017. Review.

Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.

Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 May;74(5):594-601. doi: 10.1111/anae.14580. Epub 2019 Jan 27.

• 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
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Acute Pain; Fractures, Bone; Rib Fractures; Wounds and Injuries; Pain; Neurologic Manifestations; Thoracic Injuries; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs