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Completed

NCT Number: NCT04863807

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

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.

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Key information

Conditions

Rib Fractures Acute Pain Fractures, Bone Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperiial Collge Healthcare NHS Trust

London, W2 1NY, United Kingdom

About this study

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:

  • Opioid use
  • Nausea & vomiting
  • Respiratory complications
  • Intubation & non-invasive ventilation (NIV)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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'

Treatment and study plan

regional anaesthesia

Procedure

Thoracic epidural/Erector Spinae block/Serratus Anterior block

Primary outcomes

  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 outcomes

  1. Opioid Consumption (mg/24h)

    Time frame: 72 hours

    Data regarding type of opiate use

  2. Nausea and Vomiting

    Time frame: 72 hours post block

    The incidence of nausea in the 72 hours post block will be recorded with the number of episodes in each patient

  3. Number of Patients With Respiratory Complication(s)'

    Time frame: Length of stay up to 8 weeks

    Lower respiratory tract infections: defined as raised CRP/ White Cell Count, new consolidation on CXR or antibiotics being started at clinician discretion.

    Empyema or parapneumonic effusions: defined as radiological evidence of fluid collections within the pleural space and therapeutic interventions required for treatment e.g. aspiration and drainage.

  4. Intensive Care Admission

    Time frame: Length of stay up to 8 weeks in days

    ICU admission for respiratory complications, number of days of mechanical ventilation.

  5. Intensive Care Admission

    Time frame: Length of stay up to 8 weeks in days

    Number of patients requiring intubation and ventilation

  6. Number of Days of Mechanical Ventilation

    Time frame: Length of stay up to 8 weeks in days

    Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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