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Pain Control and Recovery After Thoracic Surgery Using SPSIP Block

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

110

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Ahmet Salih Tüzen, M.D.
  • Telefonnummer: +90 535 391 55 77
  • E-post: astuzen@icloud.com

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • İzmir
      • Izmir, İzmir, Tyrkia (Türkiye), 35360
        • Rekruttering
        • Izmir Katip Celebi University Atatürk Training and Research Hospital, Karabaglar, Izmir
        • Ta kontakt med:
        • Hovedetterforsker:
          • Murat Aksun, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Fremgangsmåte: 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.
Fremgangsmåte: 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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Recovery-15 Score at 24 Hours
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Opioid Consumption During the First 24 Postoperative Hours
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Izmir Katip Celebi University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

18. september 2026

Først innsendt som oppfylte QC-kriteriene

24. september 2026

Først lagt ut (Faktiske)

30. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-SAEK-0815

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No individual participant data sharing is currently planned.

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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