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Two-Point Versus Single-Point Serratus Anterior Plane Block for Post-Thoracoscopic Surgery Analgesia

8 de julio de 2026 actualizado por: Shiyou Wei

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.

Descripción general del estudio

Descripción detallada

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 estudio

De observación

Inscripción (Estimado)

88

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

This single-center, prospective observational cohort study is conducted at Shanghai Pulmonary Hospital, Tongji University School of Medicine, China. It enrolls adults aged 18-85 years with ASA physical status I-III, scheduled for elective unilateral video-assisted thoracoscopic surgery and planned for ultrasound-guided serratus anterior plane block as routine perioperative analgesia.Eligible participants will be consecutively enrolled after written informed consent. Patients are naturally assigned to two cohorts based on the block regimen selected by the attending anesthesiologist in standard clinical practice, with a target total sample size of 88 (~44 per cohort). No study-initiated randomization or treatment intervention is applied; all clinical management follows institutional routine protocols.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otros nombres:
  • Two-Point SAPB; Double-Point Serratus Plane Block
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.
Otros nombres:
  • ingle-Point SAPB; Conventional Serratus Plane Block

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Verbal Rating Scale (VRS) Pain Score on Coughing at 24 Hours Postoperatively
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Resting Verbal Rating Scale (VRS) Pain Scores
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Within 48 hours after surgery
Proportion of patients with block-related complications, including pneumothorax, local hematoma, and local anesthetic toxicity.
Within 48 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Shiyou Wei, Tongji University Affiliated Shanghai Pulmonary Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

5 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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