- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07467291
Bloqueio SPSIP vs Bloqueio SAP para Dor Pós-VATS
Comparação do Bloqueio do Plano Intercostal do Serrátil Póstero-Superior e do Bloqueio do Plano do Serrátil Anterior para o Controlo da Dor após Cirurgia Toracoscópica Assistida por Vídeo
Comparison of Superior Serratus Posterior Intercostal Plane Block and Serratus Anterior Plane Block for Pain Management Following Video-Assisted Thoracoscopic Surgery: A Prospective Observational Cohort Study
Introduction Video-assisted thoracoscopic surgery (VATS) is associated with lower postoperative pain, shorter hospital stays, and better preservation of pulmonary function compared with conventional thoracotomy, owing to its minimally invasive nature. Although VATS was initially performed using a multi-port technique, it has evolved into a single-port approach, reflecting advances in surgical techniques and equipment. In Uniportal VATS, limiting surgical trauma to a single intercostal space may reduce the risk of chronic postoperative pain by decreasing intercostal nerve damage.
Because inadequate pain control after VATS may predispose patients to developing chronic post-thoracotomy pain syndrome (PTPS), effective postoperative analgesia is critically important. Therefore, regional analgesic techniques are recommended as part of multimodal analgesia. PROSPECT guidelines do not recommend the routine use of thoracic epidural analgesia for VATS, despite its effectiveness, because of its invasiveness; instead, they emphasize peripheral blocks such as paravertebral block and erector spinae plane block.
Although not included among first-line analgesic interventions in PROSPECT guidelines, the serratus anterior plane block (SAPB) is a widely used and well-established technique in thoracic surgery. In addition, the superior serratus posterior intercostal plane block (SPSIPB) is gaining attention in VATS surgery because of its analgesic effect covering the C3-T10 dermatomes.
Although there are studies in the literature comparing SAPB with different regional techniques, direct comparisons with SPSIPB are limited. Therefore, this prospective observational cohort study aimed to compare postoperative analgesic outcomes in patients undergoing uniportal VATS who received either ultrasound-guided SPSIPB or SAPB, with the block type selected by the attending anesthesiologist as part of routine clinical care.
Visão geral do estudo
Status
Descrição detalhada
This single-center prospective observational cohort study included adult patients undergoing elective uniportal VATS who received an ultrasound-guided serratus anterior plane block (SAPB) or serratus posterior superior intercostal plane block (SPSIPB) for postoperative analgesia. Patients were not randomized; the block type was selected by the attending anesthesiologist as part of routine clinical care. All blocks were performed with 30 mL of 0.25% bupivacaine at the end of surgery. Postoperative pain scores and rescue analgesic use were recorded in routine observation forms by recovery unit and ward nurses who were not informed of the block type. Postoperative analgesia followed a standard multimodal protocol, with 50 mg intravenous tramadol given as rescue analgesia when the resting NRS score was 4 or higher.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Elâzığ, Turquia (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adult patients undergoing elective uniportal video-assisted thoracoscopic surgery at Firat University Hospital who received either a serratus anterior plane block or a serratus posterior superior intercostal plane block for postoperative analgesia as part of routine care.
Descrição
Inclusion Criteria:
- aged 18-65 years,
- with American Society of Anesthesiologists (ASA) physical status classification I-III,
- Body Mass Index (BMI) < 35 kg/m²,
- and who read and signed the informed consent form were included.
Exclusion Criteria:
- inability to communicate in Turkish, refusal to consent,
- inability to use the numerical pain rating scale (NRS),
- allergy to local anesthetics or study-specific analgesics;
- pregnancy or breastfeeding;
- uncontrolled anxiety or substance dependence;
- history of thoracic surgery,
- trauma,
- neuromuscular or peripheral nerve disorders;
- diabetes mellitus,
- hepatic or renal insufficiency,
- coagulation disorders;
- chronic opioid or steroid use;
- widespread pain;
- anticoagulant therapy;
- infection at the block application site;
- early termination of surgery;
- absence of planned postoperative extubation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Serratus posterior superior intercostal plane block Group
Patients who received an ultrasound-guided serratus posterior superior intercostal plane block (30 mL of 0.25% bupivacaine) at the end of uniportal VATS for postoperative analgesia. The block type was selected by the attending anesthesiologist as part of routine clinical care; patients were not randomized. |
The procedure was performed with the patient in the lateral decubitus position. After a slight lateral displacement of the scapula, the scapular spine was visualized with ultrasound, and the probe was moved medially. After locating the tip of the scapular spine, the probe was placed sagittally at the superior angle of the scapula, and the third rib was visualized. The block needle was advanced craniocaudally and placed between the posterior superior serratus muscle and the third rib. Hydrodissection was performed with an injection of 2 mL of saline to confirm block needle placement. After confirming the block site, 30 mL of 0.25% bupivacaine was injected. |
|
Serratus Anterior Plane Block (SAPB) group
Patients who received an ultrasound-guided serratus anterior plane block (30 mL of 0.25% bupivacaine) at the end of uniportal VATS for postoperative analgesia. The block type was selected by the attending anesthesiologist as part of routine clinical care; patients were not randomized. |
The block was performed with the patient in the lateral decubitus position. Ultrasound-guided SAPB was performed by the same anesthesiologist with over three years of experience in ultrasound-guided regional anesthesia, using a high-frequency linear probe (LOGIQ e Ultrasound, GE HealthCare, United States). The probe was positioned parallel to the mid-axillary line, and the ribs were readily identified as hyperechogenic lines. The fifth rib was identified in the mid-axillary line. Using an in-plane technique, the needle was placed in the myofascial plane between the serratus anterior muscle and the fifth rib, and 30 mL of 0.25% bupivacaine was injected. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To determine the effectiveness of ultrasound-guided SPSIP block versus SAP block after VATS using postoperative NRS pain scores.
Prazo: NRS scores will be assessed upon admission to the post-anesthesia care unit (0 min), at 30 minutes, and at 1, 6, 12, 18, and 24 hours postoperatively.
|
The NRS score is based on the patient rating their pain on a scale from 0 to 10. Zero indicates no pain, while 10 indicates the most severe pain possible. |
NRS scores will be assessed upon admission to the post-anesthesia care unit (0 min), at 30 minutes, and at 1, 6, 12, 18, and 24 hours postoperatively.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
QoR-15 recovery score
Prazo: up to 48 hours
|
The QoR-15 (Quality of Recovery-15) scale is a patient-reported outcome questionnaire used to evaluate the quality of postoperative recovery. The QoR-15 consists of 15 items assessing five domains: pain, physical comfort, physical independence, psychological support, and emotional state. The total score ranges from 0 to 150, with higher scores indicating a better quality of recovery. |
up to 48 hours
|
|
Time to first rescue analgesia
Prazo: up to 24 hours
|
The time to first rescue analgesia, defined as the time interval between recovery from anesthesia and the first administration of rescue analgesia (50 mg intravenous tramadol for NRS ≥4), was recorded and expressed in hours. |
up to 24 hours
|
|
The total amount of rescue analgesic consumption
Prazo: up to 24 hours
|
The total amount of rescue analgesic consumption within the first 24 postoperative hours (mg) was also documented. |
up to 24 hours
|
|
The incidence of block-related complications.
Prazo: up to 48 hours
|
block-related complications such as hematoma, paralysis, hypotension or other adverse events were recorded. |
up to 48 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ahmet Aksu, MD, Firat University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Dor
- Manifestações Neurológicas
- Complicações pós-operatórias
- Processos Patológicos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Dor, Pós-operatório
- Enzimas e coenzimas
- Características da população
- Demografia
- Coenzimas
- Proteínas Ativadoras de Esfingolipídeos
- Grupos populacionais
- Saposinas
Outros números de identificação do estudo
- 43757
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 .