- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07756047
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures: a Single Centre, Randomized Controlled Trial
Rib fractures happen in about 10-20% of patients with blunt trauma and can be serious, with higher death rates in older adults. These injuries often lead to lung problems like pneumonia, collapsed lung areas (atelectasis), fluid buildup, or even respiratory failure. A major reason for this is pain-patients avoid deep breathing and coughing, which worsens lung function. Good pain control helps prevent these complications.
Opioids are commonly used for pain but can cause problems such as slowed breathing, delirium, nausea, and longer time on a ventilator. Because of this, regional anesthesia (nerve blocks) is increasingly used to control pain while reducing opioid use. Common options include epidurals, paravertebral blocks, and newer techniques like erector spinae plane (ESP) and serratus anterior plane (SAP) blocks. Continuous catheter techniques are especially useful in trauma patients because they can provide ongoing pain relief and have fewer contraindications than epidurals.
The SAP block is done at the side of the chest and works well for rib fractures in the front and side. It may not work as well for fractures in the back, although trauma may sometimes allow the anesthetic to spread further than expected.
The ESP block is done near the spine and may cover a broader area, including both front and back of the chest. It is relatively easy to perform at the bedside and is considered safe. Studies suggest it provides pain relief similar to epidurals in some patients.
There is still limited evidence directly comparing continuous SAP and ESP catheters. Only one study (using single injections) suggests ESP may provide better pain relief. It is unclear whether that difference holds true with continuous infusions, or whether SAP might be preferable because it is easier and quicker to perform.
We propose a randomized trial comparing continuous ESP and SAP catheters in patients with rib fractures to determine which provides better pain control, reduces opioid use, improves breathing outcomes, and is easier to perform in routine practice.
Our hypotheses are that ESP will provide better pain relief, SAP will be easier and safer to place, and both techniques will reduce opioid use while maintaining good patient comfort and breathing.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Traumatic rib fractures occur in 10%-20% of blunt trauma patients and are associated with significant mortality (22% and 10%, in the elderly and young patients, respectively). Patients with rib fractures are predisposed to multiple pulmonary complications including pneumonia, aspiration, pleural effusion, pulmonary embolism, atelectasis and acute respiratory distress syndrome. Effective analgesia, albeit challenging, has been found to reduce the incidence of those complications. It is postulated that pulmonary complications occur post rib fractures due to impaired pulmonary mechanics, inappropriate clearance of secretions, and atelectasis; hence the need for adequate and affective pain control.
Opioids are commonly used for analgesia in critically ill patients but they carry notable adverse effects including: respiratory depression, hemodynamic instability, tolerance, hyperalgesia, delirium and gastrointestinal side effects. They are also associated with prolonged mechanical ventilation, counteracting goals for rib fracture management. Therefore, alternative analgesic option such as regional anesthesia techniques have gained more popularity. Regional anesthetic blocks can improve analgesia and reduce opioid requirements. Options for rib fractures include thoracic epidural analgesia (TEA), paravertebral block, intercostal block, erector spinae plane block (ESP), and serratus anterior plane block (SAP).
Continuous peripheral nerve blockage has gained more popularity in trauma settings; especially continuous fascial plane catheters which can offer effective analgesia without many contraindications associated with thoracic epidurals. Frequent contraindications to thoracic epidural blocks in trauma populations have driven interest in alternative analgesic modalities such as continuous fascial plane infusions, despite the lower pneumonia rates that are associated with thoracic epidural analgesia.
Serratus Anterior Plane Block (SAP Block): The SAP block is an ultrasound guided block that involves the injection of local anesthetic superficial to the serratus anterior muscle in the mid axillary line. It provides effective analgesia for patients with anterolateral rib fractures but might be ineffective for posterior rib fractures. It consistently involves the lateral cutaneous branches of intercostal nerves, which innervate the superficial anterolateral chest wall. It might spare the intercostal nerves supplying the posterior ribs and intercostal muscles. However, a cadaveric study showed that disruption of tissue planes in trauma may promote deeper spread of local anesthetic reaching the intercostal nerves and reaching the posterior rib space.
Erector Spinae Plane Block (ESP Block): The ESP block is an ultrasound guided block which involves injection of local anesthetic into the erector spinae fascial plane. It is thought to work by blocking the lateral cutaneous and intercostal nerves with potential diffusion into the paravertebral space. It is technically easy and can be performed at bedside. Risks are low, particularly when performed under ultrasound guidance, and include hypotension, vascular puncture, contralateral spread via the epidural space, and pneumothorax. A continuous nerve catheter is typically used for rib fractures with the goal of inserting the needle midpoint of the rib levels. A randomized trial has showed that continuous ESP block is as effective is thoracic epidural analgesia for pain control in patients with unilateral rib fractures.
Addressing evidence gaps: A recent scoping review published by our research group indicated that SAP and ESP are the most common regional anesthesia techniques for acute traumatic rib fractures. There has been one head-to-head study comparing SAP to ESP that demonstrated superior analgesia in favour of ESP for traumatic rib fractures however it was designed as a single injection study. Given that the SAP catheter is potentially easier to perform (i.e., no need to place patient in lateral decubitus position and shallower sonographic target), is ESP superior to SAP catheter infusion to warrant the additional time and effort? To our best knowledge, no prospective comparative studies on SAP and ESP catheters have directly evaluated analgesic efficacy, opioid consumption, respiratory outcomes, and ease of performance between these two catheter techniques in a systematic manner. Understanding which technique provides superior analgesia while remaining technically straightforward for widespread implementation is critical for standardizing regional anesthesia practice in rib fracture management. We propose a pragmatic, randomized controlled trial (RCT) comparing ESP and SAP to identify the best regional anesthesia catheter technique regardless of the pattern of rib fracture (anterior vs. posterior) and to allow adoption of a single technique to facilitate streamlined care. This knowledge gap represents an important opportunity to advance our understanding of the two established techniques in this trauma population.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Howard Meng, MD
- Número de telefone: 416-480-4864
- E-mail: howard.meng@sunnybrook.ca
Estude backup de contato
- Nome: Lilia Kaustov, PhD
- Número de telefone: 416-480-4864
- E-mail: lilia.kaustov@sunnybrook.ca
Locais de estudo
-
-
Ontario
-
Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Contato:
- Howard Meng, MD
- Número de telefone: 416-480-4864
- E-mail: howard.meng@sunnybrook.ca
-
Investigador principal:
- Howard Meng, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age >18;
- Traumatic rib fractures (unilateral or bilateral);
- Minimum of 3 rib fractures per side;
- Admitted to hospital for <72 hours
- NRS pain score > 4 at rest or with movement for chest pain at the time of eligibility assessment
Exclusion Criteria:
- Severe traumatic brain injury (Glasgow Coma Scale < 9);
- Surgery performed/planned within 72 hours of catheter infusion start;
- Uncontrolled coagulopathy;
- Skin infection or anatomical abnormality (i.e. open fracture) at insertion sites;
- Allergy to local anesthetic;
- Chronic high dose opioid use preadmission (Morphine Equivalent Dose > 30mg per day);
- Pregnancy;
- Acute respiratory failure requiring intubation at enrolment;
- Inability to comply with Intravenous Patient-Controlled Analgesia use;
- Contraindications to nerve blocks
- High likelihood of loss to follow-up
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Erector spinae plane catheter
Participants receive erector spinae plane catheter
|
Participants receive erector spinae plane catheter infusion
|
|
Experimental: Serratus plane catheter
Participants receive serratus anterior plane catheter
|
Participants receive serratus plane catheter infusion
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain with movement
Prazo: 72 hours
|
Pain Numerical Rating Scale scores with movement from baseline through 72 hours post-placement.
Numerical Rating Scale minimum is 0, maximum is 10, higher score = worse pain.
|
72 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total opioid consumption
Prazo: 72 hours
|
Total opioid consumption (IV and oral) between the SAP and ESP groups at 24, 48, and 72 hours post-catheter placement
|
72 hours
|
|
Respiratory function
Prazo: 72 hours
|
forced expiratory volume in 1 second (FEV1), FEV1% of predicted, forced vital capacity (FVC), and peak inspiratory and expiratory flow will be measured using portable spirometry at baseline, 24 (± 4 hours), 48 (± 6 hours), and 72 (± 6 hours) hours post-catheter placement
|
72 hours
|
|
Ease of catheter insertion between techniques
Prazo: At time of catheter insertion
|
Number of skin puncture attempts
|
At time of catheter insertion
|
|
Pain at rest
Prazo: 72 hours
|
Pain Numerical Rating Scale scores at rest from baseline through 72 hours post-placement.
Numerical Rating Scale minimum is 0, maximum is 10, higher score = worse pain.
|
72 hours
|
|
Procedure related complications
Prazo: 72 hours
|
Procedural complications (vascular puncture, local anesthetic toxicity signs, pneumothorax, infection at insertion site).
|
72 hours
|
|
Duration of catheter insertion procedure
Prazo: At the time of catheter insertion
|
Time from patient positioning to final catheter insertion and confirmation (in minutes)
|
At the time of catheter insertion
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient satisfaction
Prazo: 72 hours
|
Patient satisfaction scores using Patient Global Impression of Change (PGIC)
|
72 hours
|
|
Catheter-related complications
Prazo: 72 hours
|
Catheter-related complications including infection, dislodgement, local anesthetic toxicity, and pneumothorax within the 72 hour study period
|
72 hours
|
|
Catheter function
Prazo: Through hospital admission, an average of 7 days
|
Duration of catheter function (days of infusion)
|
Through hospital admission, an average of 7 days
|
|
Hospital length of stay
Prazo: Duration of hospital admission, an average of 7 days
|
Total hospital length of stay (measured in days)
|
Duration of hospital admission, an average of 7 days
|
|
Intensive care stay
Prazo: Through hospital admission, an average of 7 days
|
Duration of intensive care stay
|
Through hospital admission, an average of 7 days
|
|
Pulmonary complications
Prazo: Through hospital admission, an average of 7 days
|
Documented pneumonia, ARDS, need for mechanical ventilation
|
Through hospital admission, an average of 7 days
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 7157
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .