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Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

16. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Outside of the US
      • Diyarbakır, Outside of the US, Tyrkiet (Türkiye), 21070
        • Rekruttering
        • Fatma Acil
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: 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 navne:
  • SPSIP-blok
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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Efterforskere

  • Ledende efterforsker: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. maj 2026

Primær færdiggørelse (Anslået)

25. oktober 2026

Studieafslutning (Anslået)

26. oktober 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07/04/2026-132

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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