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Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

16. mai 2026 oppdatert av: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial

This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.

Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.

The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Outside of the US
      • Diyarbakır, Outside of the US, Tyrkia (Türkiye), 21070
        • Rekruttering
        • Fatma Acil
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adult patients aged 18-75 years
  • ASA physical status I-III
  • Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy
  • Able to understand and use the Numeric Rating Scale (NRS)
  • Provided written informed consent

Exclusion Criteria:

  • Age >75 years
  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
  • Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued
  • Infection at the planned block site
  • Chronic opioid use or chronic pain conditions
  • Severe pulmonary disease affecting respiratory assessment
  • Neurological or psychiatric disorders interfering with pain assessment
  • Emergency surgery
  • Pregnancy or breastfeeding
  • Refusal to participate

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Serratus Posterior Superior Intercostal Plane Block with Bupivacaine
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with bupivacaine prior to surgery, in addition to standard general anesthesia and multimodal analgesia.
Fremgangsmåte: Serratus Posterior Superior Intercostal Plane Block With Bupivacaine
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
Andre navn:
  • SPSIP-blokk
Placebo komparator: Serratus Posterior Superior Intercostal Plane Block with Saline
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
Fremgangsmåte: Serratus Posterior Superior Intercostal Plane Block With Saline
Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24-hour cumulative opioid consumption
Tidsramme: 24 hours after surgery
Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).
24 hours after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to first rescue analgesia
Tidsramme: Within 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesia.
Within 24 hours after surgery
Postoperative pain intensity at rest (NRS)
Tidsramme: 4, 6, 12, and 24 hours after surgery
Pain intensity at rest measured using the Numeric Rating Scale (0-10).
4, 6, 12, and 24 hours after surgery
Postoperative pain during movement (NRS)
Tidsramme: 4, 6, 12, and 24 hours after surgery
Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10).
4, 6, 12, and 24 hours after surgery
Time to extubation
Tidsramme: From the end of surgery until extubation, assessed up to 24 hours
Time from the end of surgery to extubation.
From the end of surgery until extubation, assessed up to 24 hours
Length of intensive care unit stay
Tidsramme: Through study completion, an average of 48 hours
Duration of stay in the intensive care unit.
Through study completion, an average of 48 hours
Length of hospital stay
Tidsramme: From date of admission until discharge, up to 30 days
Total duration of hospitalization.
From date of admission until discharge, up to 30 days
Inspiratory Spirometry Test
Tidsramme: 4, 6, 12, and 24 hours after surgery
Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function.
4, 6, 12, and 24 hours after surgery

Samarbeidspartnere og etterforskere

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

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Etterforskere

  • Hovedetterforsker: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil 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)

16. mai 2026

Primær fullføring (Antatt)

25. oktober 2026

Studiet fullført (Antatt)

26. oktober 2026

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 07/04/2026-132

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

IPD-delingstidsramme

Starting 6 months and ending 36 months following article publication.

Tilgangskriterier for IPD-deling

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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