Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy
30. august 2026 oppdatert 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
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Fatma Acil, M.D.
- Telefonnummer: +905337225225
- E-post: acilfatma@gmail.com
Studiesteder
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Outside of the US
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Diyarbakır, Outside of the US, Tyrkia (Türkiye), 21070
- Rekruttering
- Fatma Acil
-
Ta kontakt med:
- Fatma Acil, M.D.
- Telefonnummer: +905337225225
- E-post: acilfatma@gmail.com
-
-
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:
- 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
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 |
|---|---|
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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.
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Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
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Eksperimentell: 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.
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Participants will receive an ultrasound-guided SPSIP block using bupivacaine.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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24-hour cumulative opioid consumption
Tidsramme: 24 hours
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Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
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24 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Static postoperative pain intensity at rest
Tidsramme: 0, 1, 2, 6, 12, and 24 hours after surgery
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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.
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0, 1, 2, 6, 12, and 24 hours after surgery
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Dynamic postoperative pain intensity during movement
Tidsramme: 0, 1, 2, 6, 12, and 24 hours after surgery
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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.
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0, 1, 2, 6, 12, and 24 hours after surgery
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Rescue analgesia requirement
Tidsramme: Within 24 hours after surgery
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Number of patients requiring rescue analgesia and total rescue analgesic consumption.
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Within 24 hours after surgery
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Time to first rescue analgesia
Tidsramme: Within 24 hours after surgery
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Time from the end of surgery to the first administration of rescue analgesia.
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Within 24 hours after surgery
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Incidence of postoperative nausea and vomiting (PONV)
Tidsramme: Within 24 hours after surgery
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Occurrence of nausea and/or vomiting during the postoperative period.
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Within 24 hours after surgery
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Block-related and opioid-related adverse events
Tidsramme: Within 24 hours after surgery
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Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.
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Within 24 hours after surgery
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Quality of Recovery-15 (QoR-15) score
Tidsramme: 24 hours after surgery
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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)
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24 hours after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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)
29. september 2026
Studiet fullført (Antatt)
30. september 2026
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 27/01/2026-38
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
Time Frame: "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
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