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Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

16. maj 2026 opdateret af: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial

This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.

The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.

Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.

The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

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:

  • Female patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
  • Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
  • Provided written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
  • Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
  • Infection or skin lesion at the injection site
  • Planned bilateral surgery or additional major surgical procedures
  • Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
  • Neurological or psychiatric conditions interfering with pain assessment
  • History of previous major thoracic or chest wall surgery on the same side
  • Pregnancy or breastfeeding
  • Refusal to participate or inability to provide informed consent

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
Placebo komparator: Placebo Group
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.
Procedure: SPSIP Block With Saline
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Eksperimentel: Serratus Posterior Superior Intercostal Plane Block Group
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.
Procedure: SPSIP Block With Bupivacaine
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
24-hour cumulative opioid consumption
Tidsramme: 24 hours
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Static postoperative pain intensity at rest
Tidsramme: 0, 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
0, 1, 2, 6, 12, and 24 hours after surgery
Dynamic postoperative pain intensity during movement
Tidsramme: 0, 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
0, 1, 2, 6, 12, and 24 hours after surgery
Rescue analgesia requirement
Tidsramme: Within 24 hours after surgery
Number of patients requiring rescue analgesia and total rescue analgesic consumption.
Within 24 hours after surgery
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
Incidence of postoperative nausea and vomiting (PONV)
Tidsramme: Within 24 hours after surgery
Occurrence of nausea and/or vomiting during the postoperative period.
Within 24 hours after surgery
Block-related and opioid-related adverse events
Tidsramme: Within 24 hours after surgery
Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.
Within 24 hours after surgery
Quality of Recovery-15 (QoR-15) score
Tidsramme: 24 hours after surgery
Quality of recovery assessed using the QoR-15 questionnaire. Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score represents a better recovery outcome (0 = extremely poor recovery, 150 = excellent recovery)
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)

29. juni 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. maj 2026

Først opslået (Faktiske)

12. 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

  • 27/01/2026-38

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

Time Frame: "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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