NCT04863807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

April 22, 2021

Results QC Date

August 8, 2023

Last Update Submit

November 9, 2024

Conditions

Keywords

epiduralerector spinae blockserratus anterior block

Outcome Measures

Primary Outcomes (1)

  • The Proportion of Patients With a Reduction in Pain

    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 Outcomes (6)

  • Opioid Consumption (mg/24h)

    72 hours

  • Nausea and Vomiting

    72 hours post block

  • Number of Patients With Respiratory Complication(s)'

    Length of stay up to 8 weeks

  • Intensive Care Admission

    Length of stay up to 8 weeks in days

  • Intensive Care Admission

    Length of stay up to 8 weeks in days

  • +1 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

Thoracic epidural/Erector Spinae block/Serratus Anterior block

Erector Spinae block for rib fracture managementSerratus Anterior block for rib fracture managementThoracic epidural for rib fracture management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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'

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperiial Collge Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (7)

  • 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. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.

    PMID: 16385313BACKGROUND
  • 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.

    PMID: 21872207BACKGROUND
  • 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.

    PMID: 30740657BACKGROUND
  • Ahn Y, Gorlinger K, Alam HB, Eikermann M. Pain-associated respiratory failure in chest trauma. Anesthesiology. 2013 Mar;118(3):701-8. doi: 10.1097/ALN.0b013e318283996b. No abstract available.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Rib FracturesAcute Pain

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Results Point of Contact

Title
Dr Alex Wickham
Organization
Imperial College Healthcare NHS Trust

Study Officials

  • Boyne Bellew

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 28, 2021

Study Start

November 11, 2020

Primary Completion

March 4, 2021

Study Completion

March 30, 2021

Last Updated

November 15, 2024

Results First Posted

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations