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SPENG Block Versus Superior Trunk Block for Shoulder Surgery: Effects on Diaphragmatic Function, Mechanical Power, Nociception, and Analgesia: A Randomized Controlled Trial

7. November 2026 aktualisiert von: Nurullah Damla, Bursa Yuksek Ihtisas Training and Research Hospital

COMPARİSON OF THE EFFECTS OF ULTRASOUND-GUİDED PREOPERATİVE SHOULDER POSTERİOR PERİCAPSULAR NERVE GROUP (SPENG) BLOCK AND SUPERİOR TRUNK BLOCK ON DİAPHRAGMATİC FUNCTİON, INTRAOPERATİVE MECHANİCAL POWER, NOCİCEPTİON (QNOX), AND POSTOPERATİVE ANALGESİA İN UPPER EXTREMİTY AND SHOULDER SURGERY: A PROSPECTİVE RANDOMİZED CONTROLLED TRİAL

Shoulder and upper extremity surgery causes severe postoperative pain. The interscalene brachial plexus block is the standard regional analgesia technique, but it causes ipsilateral hemidiaphragmatic paralysis (HDP) in almost all patients because of its proximity to the phrenic nerve. This can lead to dyspnea, hypoxemia, and atelectasis, especially in obese, elderly, or respiratory-compromised patients. The superior trunk block (STB) has been proposed as a phrenic-sparing alternative, yet HDP still occurs in about 70-76% of patients.

The Shoulder Posterior Pericapsular Nerve Group (SPENG) block is a novel pericapsular technique that targets the articular branches of the suprascapular and axillary nerves with a single injection posterior to the scapula, far from the brachial plexus and phrenic nerve. No randomized controlled trial has yet compared the SPENG block with the STB.

The aim of this prospective, randomized controlled trial is to compare preoperative ultrasound-guided SPENG block and STB in adult patients undergoing elective shoulder and upper extremity surgery under general anesthesia. The primary outcome is the incidence of hemidiaphragmatic paralysis, assessed by M-mode ultrasound measurement of diaphragmatic excursion in the post-anesthesia care unit. Secondary outcomes include intraoperative mechanical power and respiratory mechanics, intraoperative nociception (qNOX) and additional opioid requirement, Visual Analog Scale (VAS) pain scores and rescue analgesic consumption during the first 24 postoperative hours, and patient satisfaction.

The investigators hypothesize that the SPENG block will significantly reduce the incidence of hemidiaphragmatic paralysis compared with the STB while providing similar analgesic quality during the first 24 postoperative hours.

Studienübersicht

Detaillierte Beschreibung

Rationale

After superior trunk block (STB), hemidiaphragmatic paralysis (HDP) has been reported in 76.3% of patients (Kang et al., Anesthesiology 2019) and in 70.8% of patients with 20 mL of local anesthetic (Lee et al., Pain Physician 2021). Even after ultrasound-guided supraclavicular block, the reported HDP incidence is 59.5% (Ferré et al., 2019). These data suggest that all approaches at the level of the brachial plexus carry a substantial risk of phrenic nerve involvement. The SPENG block (Kilicaslan et al., Pain Med 2026) targets the articular branches of the suprascapular and axillary nerves, which provide approximately 70% of the sensory innervation of the shoulder joint, at a site posterior to the scapula. M-mode ultrasound assessment of diaphragmatic excursion is a non-invasive, repeatable, and objective bedside method for detecting block-related HDP.

Randomization and Blinding Procedures

The allocation sequence will be generated by computer (www.random.org) and concealed in sequentially numbered, opaque, sealed envelopes. Each envelope will be opened immediately before the block by the anesthesiologist performing it, who will not be involved in data collection. To maintain blinding, identical sterile dressings will be applied to both the supraclavicular region and the posterior shoulder in all patients. All block procedures will be performed with real-time needle-tip visualization, in 5 mL increments with aspiration before each increment. Lipid emulsion (20%) and resuscitation equipment will be available.

Standardized Perioperative Management

Standard monitoring will be applied in all patients. IV midazolam 1-2 mg may be given after baseline diaphragm measurement. Anesthesia will be induced with propofol 2-2.5 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane titrated to a qCON of 40-60. Fentanyl 0.5 µg/kg will be administered if qNOX remains above 60 for more than 1 minute. All patients will receive IV paracetamol 1 g and ondansetron 4 mg 30 minutes before the end of surgery. Ventilation will be standardized in volume-controlled mode (tidal volume 6-8 mL/kg ideal body weight, PEEP 5 cmH₂O, FiO₂ 50%, respiratory rate adjusted to EtCO₂ 35-40 mmHg). Plateau pressure will be measured with a 0.5-second inspiratory pause, and mechanical power will be calculated with the simplified Gattinoni formula: MP (J/min) = 0.098 × RR × VT (L) × [Ppeak - ½ × (Pplat - PEEP)]. Postoperative analgesia will consist of IV paracetamol 1 g every 6 hours and IV dexketoprofen 50 mg every 12 hours unless contraindicated, with IV tramadol 1 mg/kg (maximum 400 mg/24 h) as rescue analgesia.

Diaphragm Ultrasound Technique

The ipsilateral hemidiaphragm will be imaged in the supine position with a 2-5 MHz convex probe using a subcostal approach along the anterior axillary/midclavicular line (liver window on the right, spleen window on the left). Excursion will be measured three times in M-mode during each maneuver, and the mean value will be recorded. The postoperative measurement will be performed when the patient is fully awake and cooperative (Modified Aldrete score ≥9), using the same position, probe placement, and maneuvers, by the same blinded assessor.

Sample Size and Statistical Analysis

Sample size was calculated with G*Power 3.1.9.7 based on the primary outcome. Assuming an HDP incidence of 70% with STB and a conservatively estimated 30% with SPENG, 31 patients per group are required (two-sided α = 0.05, power = 90%). Allowing for an anticipated 15% loss, 36 patients will be enrolled per group. This sample size is also sufficient to detect a 1.5-point (SD 2.0) difference in VAS scores with 80% power. Data will be analyzed with SPSS v26.0. Relative risk with 95% confidence interval will be reported for the primary outcome. Repeated measures ANOVA or linear mixed-effects models will be used for time-dependent variables, and Kaplan-Meier analysis with the log-rank test for time to first rescue analgesic. Analyses will follow a modified intention-to-treat approach, and p < 0.05 will be considered statistically significant.

Studientyp

Interventionell

Einschreibung (Geschätzt)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Bursa
      • Bursa, Bursa, Türkei (türkiye), 16310
        • University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital
        • Kontakt:
        • Hauptermittler:
          • Korgün Ökmen, MD
        • Unterermittler:
          • Kamer Kılınç, MD
        • Unterermittler:
          • Nurullah Damla, MD
        • Unterermittler:
          • Furkan Sakın, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective arthroscopic or open shoulder/upper extremity surgery under general anesthesia
  • Ipsilateral hemidiaphragm clearly visualized with M-mode ultrasound at baseline assessment
  • Signed written informed consen

Exclusion Criteria:

  • Contraindication to regional anesthesia: local infection at the injection site, coagulopathy, or anticoagulant therapy (INR >1.5, platelet count <100,000/mm3)
  • Known allergy to local anesthetics
  • Known ipsilateral or contralateral diaphragmatic paralysis/dysfunction or history of phrenic nerve injury
  • Severe respiratory disease (COPD with mMRC dyspnea scale ≥2, restrictive lung disease, home oxygen requirement) or baseline room-air SpO2 <94%
  • Body mass index ≥35 kg/m2
  • Pre-existing neurological deficit or brachial plexopathy in the operative extremity
  • Regular opioid use for chronic pain within the past 3 months
  • Pregnancy or breastfeeding
  • Neurological or psychiatric disease preventing cooperation or understanding of the VAS scale, or refusal to give consent

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: SPENG Block

Participants will receive an ultrasound-guided Shoulder Posterior Pericapsular Nerve Group (SPENG) block with 20 mL of 0.25% bupivacaine before induction of general anesthesia.

With the patient in the lateral decubitus position, a linear probe is placed transversely just inferior to the posterior acromion. Using an in-plane medial-to-lateral approach, the needle tip is positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine is injected as a single injection.

Aktiver Komparator: Superior Trunk Block

Participants will receive an ultrasound-guided superior trunk block with 20 mL of 0.25% bupivacaine before induction of general anesthesia.

With the patient supine and the head turned to the contralateral side, the superior trunk is identified at the level just proximal to the origin of the suprascapular nerve. Using an in-plane lateral-to-medial approach, 20 mL of 0.25% bupivacaine is injected, half anterior and half posterior to the superior trunk.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Hemidiaphragmatic Paralysis
Zeitfenster: Baseline (before block) and approximately 30 minutes after admission to the post-anesthesia care unit

Ipsilateral diaphragmatic excursion will be measured with M-mode ultrasound during the sniff maneuver (mean of three measurements). Hemidiaphragmatic paralysis is defined as a ≥25% reduction in excursion from baseline and graded as none (<25%), partial (25-75%), or complete (>75% reduction or paradoxical movement).

Baseline (before block) and approximately 30 minutes after admission to the post-anesthesia care unit

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Diaphragmatic Excursion
Zeitfenster: Baseline (before block) and approximately 30 minutes after admission to the post-anesthesia care unit

Percentage change in ipsilateral diaphragmatic excursion (mm) measured with M-mode ultrasound during quiet breathing, deep inspiration, and sniff maneuver, calculated as ((T0 - T1) / T0) × 100.

Baseline (before block) and approximately 30 minutes after admission to the post-anesthesia care unit
Intraoperative Mechanical Power
Zeitfenster: 10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery

Mechanical power (J/min) calculated with the simplified Gattinoni formula: 0.098 × RR × VT (L) × [Ppeak - ½ × (Pplat - PEEP)].

10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery
Intraoperative Driving Pressure and Static Compliance
Zeitfenster: 10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery

Driving pressure (Pplat - PEEP, cmH2O) and static compliance (VT / [Pplat - PEEP], mL/cmH2O).

10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery
Intraoperative Nociception (qNOX)
Zeitfenster: Before induction, at intubation, surgical positioning, skin incision/first portal entry, every 15 minutes during surgery, and at the end of surgery

qNOX values recorded with the Conox monitor and the percentage of anesthesia time with qNOX >60.

Before induction, at intubation, surgical positioning, skin incision/first portal entry, every 15 minutes during surgery, and at the end of surgery
Intraoperative Supplemental Fentanyl Consumption
Zeitfenster: Intraoperative period

Total supplemental fentanyl (µg) and number of supplemental doses administered for qNOX >60 lasting longer than 1 minute.

Intraoperative period
Postoperative Pain Scores
Zeitfenster: On arrival at the post-anesthesia care unit, at 30 minutes, and at 2, 4, 6, 12, and 24 hours postoperatively

Pain assessed with the Visual Analog Scale (0-10 cm; 0 = no pain, 10 = worst imaginable pain) at rest at all time points, and additionally during movement at 24 hours.

On arrival at the post-anesthesia care unit, at 30 minutes, and at 2, 4, 6, 12, and 24 hours postoperatively
Time to First Rescue Analgesic
Zeitfenster: Postoperative 24 hours

Time (minutes) from the end of surgery to the first administration of rescue tramadol for VAS ≥4.

Postoperative 24 hours
Total Rescue Tramadol Consumption
Zeitfenster: Postoperative 24 hours

Total intravenous tramadol (mg) administered as rescue analgesia.

Postoperative 24 hours
Patient Satisfaction
Zeitfenster: Postoperative 24 hours

Assessed with a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).

Postoperative 24 hours
Incidence of Block-Related Adverse Events
Zeitfenster: Postoperative 24 hours

Horner syndrome, hoarseness, vascular puncture, signs of local anesthetic systemic toxicity, postoperative nausea and vomiting, paresthesia, dyspnea, and need for supplemental oxygen.

Postoperative 24 hours

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Block Performance Time
Zeitfenster: During block procedure

Total time (minutes) for ultrasound imaging and needling.

During block procedure
Motor Block of the Shoulder
Zeitfenster: 20 minutes after block

Shoulder abduction (axillary nerve) and external rotation (suprascapular nerve) strength assessed with a 3-point scale (2 = normal strength, 1 = reduced strength, 0 = no movement against gravity).

20 minutes after block

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Korgün Ökmen, University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

7. November 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. November 2026

Zuerst gepostet (Tatsächlich)

13. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared, as the informed consent form does not include permission for data sharing and the Turkish Personal Data Protection Law (KVKK) restricts the disclosure of personal health data. Aggregated results will be published in a peer-reviewed journal.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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