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Interscalene Brachial Plexus Block Versus Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery (SISA)

25. juni 2026 opdateret af: Ferit Yetik

Comparison of Interscalene Brachial Plexus Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Controlled Trial

Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. The serratus posterior superior intercostal plane (SPSIP) block is a recently described fascial plane block that may provide effective analgesia while avoiding some of the limitations of ISB.

This prospective, randomized, double-blind controlled trial aims to compare the analgesic efficacy of ISB and SPSIP block in patients undergoing elective arthroscopic shoulder surgery under general anesthesia. The primary outcome is total postoperative opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, quality of recovery, time to first rescue analgesia, rescue analgesic requirements, intraoperative opioid consumption, sensory block distribution, motor block characteristics, and block-related complications.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Postoperative pain following arthroscopic shoulder surgery can adversely affect patient comfort, early mobilization, rehabilitation, and overall recovery. Although the interscalene brachial plexus block is considered the reference regional anesthesia technique for shoulder surgery, its use may be limited by adverse effects such as hemidiaphragmatic paresis, phrenic nerve involvement, and upper extremity motor weakness.

The serratus posterior superior intercostal plane block is a novel ultrasound-guided fascial plane block targeting the posterior thoracic region. Preliminary evidence suggests that it may provide analgesia extending to the shoulder area through spread to cervical and upper thoracic dermatomes. However, comparative clinical evidence between SPSIP block and ISB for arthroscopic shoulder surgery remains limited.

In this prospective, randomized, double-blind controlled trial, eligible adult patients scheduled for elective arthroscopic shoulder surgery under general anesthesia will be randomly assigned to receive either an ultrasound-guided ISB or SPSIP block. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.

The primary endpoint will be total opioid consumption during the first 24 postoperative hours. Secondary endpoints will include postoperative Numeric Rating Scale (NRS) pain scores at predefined time points, quality of recovery assessed with the QoR-15 questionnaire, intraoperative opioid consumption, time to first rescue analgesic requirement, total rescue analgesic consumption, sensory block distribution, motor block assessment, and block-related adverse events.

The study aims to determine whether SPSIP block can provide postoperative analgesia comparable to ISB while potentially reducing complications associated with brachial plexus blockade.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
    • Nilüfer
      • Bursa, Nilüfer, Tyrkiet (Türkiye)
        • Rekruttering
        • Bursa City Hospital
        • Underforsker:
          • Onur Güneş, MD
        • Ledende efterforsker:
          • Mürsel Ekinci, MD
        • Kontakt:
        • 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:

  • Age between 18 and 75 years
  • ASA physical status I, II, or III
  • Scheduled for elective arthroscopic shoulder surgery under general anesthesia
  • Provision of written informed consent

Exclusion Criteria:

  • Refusal to participate in the study
  • Coagulopathy
  • Current anticoagulant therapy
  • Infection at the block site
  • Previous surgery involving the planned block site
  • Known allergy or history of toxicity to local anesthetics
  • Hepatic failure
  • Renal failure
  • Uncontrolled diabetes mellitus
  • Cognitive impairment or mental disability preventing reliable assessment
  • Chronic opioid use or ongoing chronic pain treatment
  • Pregnancy, suspected pregnancy, or breastfeeding
  • Chronic pulmonary disease (e.g., COPD or asthma)
  • Failed block

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interscalene Brachial Plexus Block Group
Participants receive an ultrasound-guided interscalene brachial plexus block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery.
Procedure: Interscalene Brachial Plexus Block
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
Medicin: Bupivacaine
Bupivacaine administered for ultrasound-guided regional anesthesia block.
Eksperimentel: Serratus Posterior Superior Intercostal Plane Block Group
Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery.
Medicin: Bupivacaine
Bupivacaine administered for ultrasound-guided regional anesthesia block.
Procedure: Serratus Posterior Superior Intercostal Plane Block
Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Opioid Consumption During the First 24 Postoperative Hours
Tidsramme: 24 hours after surgery
Comparison of total postoperative opioid consumption between the interscalene brachial plexus block group and the serratus posterior superior intercostal plane block group during the first 24 hours after surgery.
24 hours after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative Remifentanil Consumption
Tidsramme: During surgery
Total remifentanil consumption during surgery.
During surgery
Postoperative Pain Scores
Tidsramme: 0, 2, 4, 8, 16, and 24 hours after surgery
Numeric Rating Scale (NRS) pain scores at rest and during movement, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery (QoR-15)
Tidsramme: 24 hours after surgery
Quality of Recovery-15 (QoR-15) score assessed 24 hours after surgery. Scores range from 0 to 150, with higher scores indicating better postoperative recovery and patient satisfaction.
24 hours after surgery
Time to First Rescue Analgesic Requirement
Tidsramme: First 24 postoperative hours
Time elapsed from the end of surgery to the first rescue analgesic administration.
First 24 postoperative hours
Rescue Analgesic Consumption
Tidsramme: First 24 postoperative hours
Total rescue analgesic consumption during the postoperative period.
First 24 postoperative hours
Block-Related and Opioid-Related Complications
Tidsramme: First 24 postoperative hours
Incidence of adverse events related to regional anesthesia techniques and opioid administration.
First 24 postoperative hours

Samarbejdspartnere og efterforskere

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

Sponsor

Ferit Yetik

Samarbejdspartnere

Bursa Sehir Hastanesi

Efterforskere

  • Ledende efterforsker: Mürsel Ekinci, University of Health Sciences, Bursa Faculty of Medicine, Bursa City 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)

25. juni 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

15. december 2026

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-AKD-92 (Anden identifikator: Bursa City Hospital Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

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INGEN

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