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

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863807
• Other study ID #: 19SM5668
• Secondary ID: 276933
• Status: Completed
• Start date: November 11, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 30, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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'

Related Conditions & MeSH terms

• Acute Pain
• Fractures, Bone
• Pain, Acute
• Rib Fractures

Intervention

Procedure:
• Regional Anaesthesia
Thoracic epidural/Erector Spinae block/Serratus Anterior block

Locations

Country	Name	City	State
United Kingdom	Imperiial Collge Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Type	Data regarding type of opiate use	72 hours
Secondary	Opioid mode of delivery	Mode of delivery of opioids	72 hours
Secondary	Opioid use	Dosage requirement every 24 hours for a total of 72 hours	72 hours
Secondary	Opioid complication(s)	Complications associated with opiates such as constipation, delirium and respiratory depression.	72 hours
Secondary	Nausea and vomiting	The incidence of nausea and vomiting pre-chest wall block	Time zero
Secondary	NUmber of nausea and vomiting episodes	The incidence of nausea in the 72 hours post block will be recorded with the number of episodes	72 hours post block
Secondary	Anti-emetic(s) used	The incidence of nausea in the 72 hours post block will be recorded with the number of anti-emetic medications required to treat.	72 hours post block
Secondary	Lower respiratory tract infections	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.	Length of stay up 8 weeks
Secondary	Respiratory complication(s)	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.	Length of stay up to 8 weeks
Secondary	Intensive care admission for respiratory complications	ICU admission for respiratory complications	Length of stay up to 8 weeks
Secondary	Intensive care admission	Number of patients requiring intubation and ventilation	Length of stay up to 8 weeks
Secondary	Intensive care mechanical ventilation	Number of days of mechanical ventilation	Length of stay up to 8 weeks