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Pain Control and Recovery After Thoracic Surgery Using SPSIP Block

2 novembre 2026 aggiornato da: Ahmet Salih Tüzen, MD, Izmir Katip Celebi University

Comparison of the Analgesic Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Among Different Thoracic Surgical Procedures: A Prospective Observational Cohort Study

Thoracic surgery is frequently associated with significant postoperative pain, which may impair respiratory function, mobilization, recovery, and patient satisfaction. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block that may provide effective analgesia after thoracic surgery. This prospective observational cohort study will evaluate the analgesic effectiveness and postoperative recovery associated with SPSIP block in adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy. All patients will receive SPSIP block as part of routine institutional multimodal analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include postoperative pain intensity, opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, pulmonary complications, patient satisfaction, length of hospital stay, and chronic postoperative pain.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Postoperative pain remains an important clinical concern following thoracic surgery. Inadequate analgesia may adversely affect deep breathing, coughing, pulmonary toilet, early mobilization, and overall postoperative recovery. Although minimally invasive thoracic surgical techniques have reduced surgical trauma, clinically relevant postoperative pain may still occur. Regional anesthesia techniques are commonly incorporated into multimodal analgesic strategies for thoracic surgery. Fascial plane blocks have emerged as alternatives to more invasive regional techniques because of their relative technical simplicity and potential safety advantages. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block with promising analgesic efficacy; however, evidence regarding whether its effectiveness differs according to the invasiveness of the thoracic surgical procedure remains limited.

This prospective observational cohort study will include adult patients undergoing elective thoracic surgery under general anesthesia who receive an ultrasound-guided SPSIP block as part of routine institutional multimodal analgesia. Patients will be categorized according to the surgical procedure into three predefined cohorts: minor video-assisted thoracoscopic surgery (VATS), major VATS, and thoracotomy. The SPSIP block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic. No participant will be assigned to a surgical procedure or regional anesthesia technique for research purposes.

The primary objective is to compare postoperative quality of recovery among the three surgical cohorts. Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15) at 24 hours after surgery, with higher scores indicating better postoperative recovery.

Secondary outcomes will include postoperative opioid consumption expressed as morphine milligram equivalents, pain intensity measured using the Numeric Rating Scale at rest and during coughing, time to first rescue analgesia, total rescue analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, hemodynamic variables, pulmonary complications, time to ambulation, length of hospital stay, and patient satisfaction. Pain intensity will be evaluated in the post-anesthesia care unit and at 2, 6, 12, and 24 hours after surgery. Patients will also be followed for clinically relevant postoperative outcomes, including hospital readmission within 30 days and chronic postoperative pain at 3 and 6 months. Potential block-related complications, including local anesthetic systemic toxicity, pneumothorax, hematoma, and infection, will be recorded.

The study is designed to determine whether postoperative recovery and analgesic outcomes associated with the same SPSIP block technique differ according to the type and invasiveness of thoracic surgery.

Tipo di studio

Osservativo

Iscrizione (Stimato)

110

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Ahmet Salih Tüzen, M.D.
  • Numero di telefono: +90 535 391 55 77
  • Email: astuzen@icloud.com

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
    • İzmir
      • Izmir, İzmir, Turchia (Türkiye), 35360
        • Reclutamento
        • Izmir Katip Celebi University Atatürk Training and Research Hospital, Karabaglar, Izmir
        • Contatto:
        • Investigatore principale:
          • Murat Aksun, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Adults undergoing elective minor VATS, major VATS, or thoracotomy under general anesthesia who receive SPSIP block as part of routine multimodal analgesia

Descrizione

Inclusion Criteria:

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thoracic surgery
  • Undergoing minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy
  • Planned ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine multimodal analgesia
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Patient refusal
  • Known allergy to amide local anesthetics
  • Coagulopathy
  • Therapeutic anticoagulation incompatible with regional anesthesia
  • Infection at the planned block injection site
  • Pregnancy
  • Emergency surgery
  • Chronic opioid therapy for more than 3 months
  • Chronic pain syndrome
  • Cognitive impairment that prevents reliable study assessments
  • Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Minor VATS

Adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Procedura: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.
Major VATS

Adult patients undergoing elective major video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Procedura: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.
Thoracotomy

Adult patients undergoing elective thoracotomy under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Procedura: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Recovery-15 Score at 24 Hours
Lasso di tempo: 24 hours after surgery

Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better postoperative recovery. QoR-15 scores will be compared among the minor VATS, major VATS, and thoracotomy cohorts.
24 hours after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Opioid Consumption During the First 24 Postoperative Hours
Lasso di tempo: 0 to 24 hours after surgery

Total opioid consumption during the first 24 hours after surgery will be calculated and converted to morphine milligram equivalents (MME) to allow comparison among the three surgical cohorts.
0 to 24 hours after surgery
Pain Intensity at Rest Upon Admission to the PACU
Lasso di tempo: Upon admission to the post-anesthesia care unit (PACU)

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Upon admission to the post-anesthesia care unit (PACU)
Pain Intensity at Rest at 2 Hours
Lasso di tempo: 2 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
2 hours after the end of surgery
Pain Intensity at Rest at 6 Hours
Lasso di tempo: 6 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
6 hours after the end of surgery
Pain Intensity at Rest at 12 Hours
Lasso di tempo: 12 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
12 hours after the end of surgery
Pain Intensity at Rest at 24 Hours
Lasso di tempo: 24 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
24 hours after the end of surgery
Pain Intensity During Coughing Upon Admission to the PACU
Lasso di tempo: Upon admission to the post-anesthesia care unit (PACU)

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Upon admission to the post-anesthesia care unit (PACU)
Pain Intensity During Coughing at 2 Hours
Lasso di tempo: 2 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
2 hours after the end of surgery
Pain Intensity During Coughing at 6 Hours
Lasso di tempo: 6 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
6 hours after the end of surgery
Pain Intensity During Coughing at 12 Hours
Lasso di tempo: 12 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
12 hours after the end of surgery
Pain Intensity During Coughing at 24 Hours
Lasso di tempo: 24 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
24 hours after the end of surgery
Time to First Rescue Analgesic Administration
Lasso di tempo: 0 to 24 hours after surgery

Time from completion of surgery to the first administration of rescue analgesic medication will be recorded.
0 to 24 hours after surgery
Total Rescue Analgesic Requirement
Lasso di tempo: 0 to 24 hours after surgery

The total amount of rescue analgesic medication administered during the postoperative observation period will be recorded.
0 to 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Lasso di tempo: 0 to 24 hours after surgery

The number of participants experiencing postoperative nausea and/or vomiting will be recorded.
0 to 24 hours after surgery
Requirement for Rescue Antiemetic Medication
Lasso di tempo: 0 to 24 hours after surgery

The number of participants requiring rescue antiemetic medication will be recorded.
0 to 24 hours after surgery
Time to First Postoperative Ambulation
Lasso di tempo: From the end of surgery until first postoperative ambulation or hospital discharge, whichever occurs first, assessed up to 30 days after surgery.

Time from the end of surgery to the patient's first postoperative ambulation will be recorded in hours. First ambulation will be defined as the first documented occasion on which the patient gets out of bed and ambulates with or without assistance. Patients who do not ambulate before hospital discharge will be considered not to have experienced the event during the observation period.
From the end of surgery until first postoperative ambulation or hospital discharge, whichever occurs first, assessed up to 30 days after surgery.
Postoperative Length of Hospital Stay
Lasso di tempo: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

The duration of postoperative hospitalization will be recorded in days, calculated from the end of surgery until hospital discharge.
From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Chronic Postoperative Pain at 3 Months
Lasso di tempo: 3 months after surgery

Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 3 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
3 months after surgery
Chronic Postoperative Pain at 6 Months
Lasso di tempo: 6 months after surgery

Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 6 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
6 months after surgery
Hospital Readmission Within 30 Days
Lasso di tempo: Within 30 days after surgery

The number of participants requiring unplanned hospital readmission within 30 days after surgery will be recorded.
Within 30 days after surgery
Incidence of SPSIP Block-Related Complications
Lasso di tempo: From block performance until hospital discharge, assessed up to 30 days after surgery.

The number of participants who develop one or more complications related to the Serratus Posterior Superior Intercostal Plane (SPSIP) block will be recorded. Complications will include local anesthetic systemic toxicity, pneumothorax attributable to the block, hematoma at the block site, and infection at the block site.
From block performance until hospital discharge, assessed up to 30 days after surgery.
Incidence of Postoperative Pulmonary Complications
Lasso di tempo: From the end of surgery until hospital discharge, up to 30 days

Postoperative pulmonary complications will include pneumonia, clinically significant atelectasis requiring therapeutic intervention, bronchospasm requiring treatment, aspiration pneumonitis, acute respiratory distress syndrome, postoperative respiratory failure requiring non-invasive ventilatory support or reintubation, or an unplanned escalation in respiratory support. Participants experiencing at least one of these events will be considered to have a postoperative pulmonary complication.
From the end of surgery until hospital discharge, up to 30 days
Patient Satisfaction With Postoperative Analgesia
Lasso di tempo: 24 hours after surgery

Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction with postoperative analgesia.
24 hours after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Izmir Katip Celebi University

Investigatori

  • Investigatore principale: Murat Aksun, M.D., Izmir Katip Celebi University Atatürk Training and Research Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

18 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 settembre 2026

Primo Inserito (Effettivo)

30 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-SAEK-0815

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No individual participant data sharing is currently planned.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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