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Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

30 augusti 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Turkiet (Türkiye)
    • Outside of the US
      • Diyarbakır, Outside of the US, Turkiet (Türkiye), 21070
        • Rekrytering
        • Fatma Acil
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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.
Procedur: SPSIP Block With Saline
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Experimentell: 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.
Procedur: SPSIP Block With Bupivacaine
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
24-hour cumulative opioid consumption
Tidsram: 24 hours
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
24 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Static postoperative pain intensity at rest
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 maj 2026

Primärt slutförande (Beräknad)

29 september 2026

Avslutad studie (Beräknad)

30 september 2026

Studieregistreringsdatum

Först inskickad

5 maj 2026

Först inskickad som uppfyllde QC-kriterierna

5 maj 2026

Första postat (Faktisk)

12 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 27/01/2026-38

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

Time Frame: "Starting 6 months and ending 36 months following article publication

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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