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- Ensaio Clínico NCT07700823
Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia
Comparison of Ultrasound-Guided Two-Point Combined vs Single-Point Serratus Anterior Plane Block for Postoperative Analgesia in Thoracoscopic Surgery: A Prospective Observational Cohort Study
Postoperative pain remains a common clinical challenge in patients undergoing video-assisted thoracoscopic surgery (VATS), impairing early recovery and increasing opioid consumption. The serratus anterior plane block (SAPB) is a widely used regional analgesic technique for thoracic surgery, but conventional single-point injection may have limited spread of local anesthetics, resulting in suboptimal analgesia in some patients. Preliminary anatomical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and better analgesic efficacy.
This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 adult patients scheduled for elective unilateral VATS will be consecutively enrolled and naturally assigned to either the two-point combined SAPB group (injection at the 3rd and 5th rib levels, total 30 ml local anesthetic) or the single-point SAPB group (injection at the 5th rib level, 30 ml local anesthetic) according to routine clinical practice.
The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and Quality of Recovery-15 (QoR-15) scores. This study aims to provide clinical evidence for optimizing perioperative analgesic strategies for thoracoscopic surgery.
Visão geral do estudo
Status
Condições
Descrição detalhada
Study Background Video-assisted thoracoscopic surgery (VATS) is the standard minimally invasive approach for thoracic diseases, yet over 60% of patients experience moderate-to-severe postoperative pain within 24 hours, which impairs respiratory function, increases opioid consumption and prolongs hospital stay. The serratus anterior plane block (SAPB) is a widely used fascial plane block for thoracic analgesia, but conventional single-point injection often yields inconsistent anesthetic spread due to individual anatomical variations, resulting in suboptimal analgesia in some patients. Preliminary anatomical and clinical evidence suggests that two-point combined SAPB may achieve wider dermatomal coverage and superior analgesic efficacy, but confirmatory evidence in VATS patients remains limited.
Study Design & Population This is a single-center, prospective observational cohort study conducted at Shanghai Pulmonary Hospital, China. A total of 88 eligible patients aged 18-85 years with ASA physical status I-III, scheduled for elective unilateral VATS and planned for perioperative SAPB, will be consecutively enrolled. Patients will be naturally allocated to the two-point group or single-point group according to the clinical regimen chosen by the attending anesthesiologist, with no researcher-initiated randomization. Exclusion criteria include local infection at the puncture site, allergy to amide local anesthetics, chronic opioid use, severe coagulopathy, and cognitive impairment precluding pain assessment.
Interventions & Outcomes All blocks are performed under ultrasound guidance by anesthesiologists with ≥50 prior SAPB experiences. The two-point group receives 15 ml of local anesthetic at both the 3rd and 5th rib levels (total 30 ml); the single-point group receives 30 ml at the 5th rib level. Standardized general anesthesia and postoperative analgesia protocols are applied uniformly to all patients. The primary outcome is the verbal rating scale (VRS) pain score on coughing at 24 hours postoperatively. Secondary outcomes include resting and dynamic pain scores at multiple time points, cumulative opioid consumption at 24 and 48 hours, incidence of postoperative nausea and vomiting, block-related complications, length of hospital stay, and QoR-15 recovery quality scores.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Shiyou Wei
- Número de telefone: 15601680288
- E-mail: lovewishyou@tongji.edu.cn
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Aged 18 to 85 years at enrollment, regardless of sex
- American Society of Anesthesiologists (ASA) physical status grade I to III
- Scheduled for elective unilateral video-assisted thoracoscopic surgery
- Planned to receive ultrasound-guided SAPB for routine perioperative analgesia
- Able to understand study procedures and provide written informed consent
Exclusion Criteria:
- Local infection or skin lesion at the block puncture site
- Known hypersensitivity or allergy to amide local anesthetics
- Preexisting sensory abnormality in the chest wall surgical area
- Chronic opioid use for > 3 months, history of chronic pain syndrome, or history of opioid abuse
- Severe coagulopathy (international normalized ratio > 1.5 or platelet count < 80 × 10⁹/L)
- Cognitive impairment or inability to cooperate with postoperative pain assessment
- Refusal to provide written informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Two-Point SAPB Group
Patients in this cohort receive ultrasound-guided two-point combined serratus anterior plane block for perioperative analgesia as part of routine clinical practice.
A total of 30 mL local anesthetic is administered, with 15 mL injected deep to the serratus anterior muscle at the 3rd rib level and 15 mL at the 5th rib level.
|
Ultrasound-guided fascial plane block for perioperative thoracic analgesia.
Local anesthetic is deposited deep to the serratus anterior muscle at two separate rib levels, with equal volume split between the 3rd and 5th intercostal spaces.
Outros nomes:
|
|
Single-Point SAPB Group
Patients in this cohort receive ultrasound-guided single-point serratus anterior plane block for perioperative analgesia as part of routine clinical practice.
A total of 30 mL local anesthetic is injected deep to the serratus anterior muscle at the 5th rib level in a single administration.
|
Ultrasound-guided fascial plane block for perioperative thoracic analgesia.
A single bolus of local anesthetic is deposited deep to the serratus anterior muscle at the 5th intercostal level.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Verbal Rating Scale (VRS) Pain Score on Coughing at 24 Hours Postoperatively
Prazo: 24 hours after surgery
|
Dynamic pain intensity assessed using a 0-10 verbal rating scale (0 = no pain, 10 = worst imaginable pain) when the patient performs coughing.
|
24 hours after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Resting Verbal Rating Scale (VRS) Pain Scores
Prazo: 1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
|
Resting pain measured using a 0-10 verbal rating scale at multiple postoperative time points.
|
1 hour, 6 hours, 12 hours, 24 hours, 48 hours after surgery
|
|
Cumulative Postoperative Opioid Consumption
Prazo: 24 hours and 48 hours after surgery
|
Total opioid consumption after surgery, converted to standard intravenous morphine equivalents.
|
24 hours and 48 hours after surgery
|
|
Incidence of Postoperative Nausea and Vomiting (PONV)
Prazo: Within 48 hours after surgery
|
Proportion of patients experiencing nausea and/or vomiting within 48 hours after surgery.
|
Within 48 hours after surgery
|
|
Incidence of Block-Related Adverse Events
Prazo: Within 48 hours after surgery
|
Proportion of patients with block-related complications, including pneumothorax, local hematoma, and local anesthetic toxicity.
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Within 48 hours after surgery
|
|
Quality of Recovery-15 (QoR-15) Score
Prazo: 24 hours and 48 hours after surgery
|
Patient-reported postoperative recovery quality assessed by the 15-item Quality of Recovery scale (total score range 0-150; higher score indicates better recovery quality).
|
24 hours and 48 hours after surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shiyou Wei, Tongji University Affiliated Shanghai Pulmonary Hospital
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026LY0735
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