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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 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Bursa
      • Bursa, Bursa, Turchia (Türkiye), 16310
        • University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital
        • Contatto:
        • Investigatore principale:
          • Korgün Ökmen, MD
        • Sub-investigatore:
          • Kamer Kılınç, MD
        • Sub-investigatore:
          • Nurullah Damla, MD
        • Sub-investigatore:
          • Furkan Sakın, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Hemidiaphragmatic Paralysis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Diaphragmatic Excursion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Postoperative 24 hours

Total intravenous tramadol (mg) administered as rescue analgesia.

Postoperative 24 hours
Patient Satisfaction
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Block Performance Time
Lasso di tempo: During block procedure

Total time (minutes) for ultrasound imaging and needling.

During block procedure
Motor Block of the Shoulder
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 dicembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

7 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • BursaYIERH-AR-ND-02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .