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

November 9, 2024 updated by: Imperial College Healthcare NHS Trust

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

389

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, W2 1NY
        • Imperiial Collge Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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'

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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'
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'
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'
Thoracic epidural/Erector Spinae block/Serratus Anterior block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption (mg/24h)
Time Frame: 72 hours
Data regarding type of opiate use
72 hours
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
72 hours post block
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.

Length of stay up to 8 weeks
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.
Length of stay up to 8 weeks in days
Intensive Care Admission
Time Frame: Length of stay up to 8 weeks in days
Number of patients requiring intubation and ventilation
Length of stay up to 8 weeks in days
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
Length of stay up to 8 weeks in days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 19SM5668
  • 276933 (Other Identifier: HRA and Health and Care Research Wales (HCRW))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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