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SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)

12 agosto 2026 aggiornato da: Murat Kaykaç, Izmir City Hospital

Analgesic Efficacy of the Shoulder Posterior Pericapsular Nerve Group Block Versus Combined Posterior Suprascapular and Axillary Nerve Blocks for Shoulder Arthroscopy: A Randomized, Blinded, Non-Inferiority Trial

This prospective, randomized, patient- and assessor-blinded, single-center non-inferiority trial will compare the analgesic efficacy of the Shoulder Posterior Pericapsular Nerve Group (SPENG) block with combined posterior suprascapular and axillary nerve blocks in adults undergoing elective shoulder arthroscopy under general anesthesia. Both groups will receive the same total volume and concentration of local anesthetic. The primary outcome will be the highest resting Numeric Rating Scale pain score recorded during the first 24 postoperative hours. Secondary outcomes will include block performance time, sensory block success in suprascapular and axillary nerve territories, opioid consumption, time to rescue analgesia, motor function, diaphragmatic function, postoperative recovery quality, patient satisfaction, and block-related complications.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

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

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 to 70 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled to undergo elective shoulder arthroscopy under general anesthesia
  • Able to understand the Numeric Rating Scale for pain assessment
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to local anesthetics used in the study
  • Infection at the planned block injection site
  • Coagulopathy or ongoing anticoagulant therapy that cannot be appropriately interrupted for peripheral nerve block
  • Pre-existing neurological deficit affecting the operative upper extremity
  • Moderate or severe pulmonary disease
  • Known diaphragmatic dysfunction
  • Chronic opioid use
  • Chronic pain syndrome
  • Body mass index greater than 35 kg/m²
  • Pregnancy or breastfeeding
  • Inability to understand or reliably report Numeric Rating Scale pain scores
  • Inadequate sonographic window preventing safe performance of the allocated block technique before randomization

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 assigned to this group will receive an ultrasound-guided Shoulder Posterior Pericapsular Nerve Group (SPENG) block before general anesthesia for shoulder arthroscopy. A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered as a single injection between the posterior glenoid rim and the deep surface of the infraspinatus muscle.
Procedura: Shoulder Posterior Pericapsular Nerve Group (SPENG) Block
An ultrasound-guided single-injection posterior pericapsular block. With the participant in the lateral decubitus position and the operative shoulder uppermost, a high-frequency linear ultrasound transducer will be placed transversely immediately inferior to the posterior acromion. After identification of the humeral head, articular cartilage, infraspinatus muscle, and posterior glenoid rim, a block needle will be advanced in-plane in a medial-to-lateral direction. The needle tip will be positioned between the posterior glenoid rim and the deep surface of the infraspinatus muscle, and 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be injected.
Altri nomi:
  • SPENG Block
Comparatore attivo: Posterior Suprascapular and Axillary Nerve Blocks
Participants assigned to this group will receive ultrasound-guided posterior suprascapular and axillary nerve blocks before general anesthesia for shoulder arthroscopy. A total of 20 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered, consisting of 10 mL for the posterior suprascapular nerve block and 10 mL for the axillary nerve block.
Procedura: Combined Posterior Suprascapular and Axillary Nerve Blocks
wo ultrasound-guided nerve blocks will be performed. For the posterior suprascapular nerve block, the suprascapular nerve will be identified in the suprascapular notch region beneath the supraspinatus muscle, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered. For the axillary nerve block, the posterior humeral circumflex artery will be identified using color Doppler in the quadrilateral space, and 10 mL of 0.25% bupivacaine with epinephrine 1:200,000 will be administered adjacent to the axillary nerve.
Altri nomi:
  • Posterior Shoulder Block

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Lasso di tempo: From arrival in the post-anesthesia care unit through 24 hours after surgery
Resting postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). For each participant, the highest resting NRS score recorded during the first 24 postoperative hours will be used as the primary outcome. Scheduled assessments will be performed on arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery. Resting NRS scores obtained immediately before rescue analgesic administration outside these scheduled assessments will also be included when determining the highest value.
From arrival in the post-anesthesia care unit through 24 hours after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants With Complete Dual-Target Sensory Block Success
Lasso di tempo: 30 minutes after block completion
Cold sensation will be assessed over the posterior shoulder (suprascapular nerve territory) and lateral deltoid region (axillary nerve territory) using a 3-point scale: 0 = absent sensation, 1 = reduced sensation, and 2 = normal sensation. Suprascapular sensory component success will be defined as a reduction of at least one grade from baseline in the posterior shoulder region. Axillary sensory component success will be defined as a reduction of at least one grade from baseline in the lateral deltoid region. Complete dual-target sensory block success will require successful sensory blockade in both territories in the same participant.
30 minutes after block completion
Cumulative Opioid Consumption During the First 24 Postoperative Hours
Lasso di tempo: From arrival in the post-anesthesia care unit through 24 hours after surgery
All rescue opioid analgesics administered during the first 24 postoperative hours will be recorded and converted to intravenous morphine-equivalent dose for comparison between groups.
From arrival in the post-anesthesia care unit through 24 hours after surgery
Time to First Rescue Analgesic
Lasso di tempo: From block completion through 24 hours after surgery
Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain.
From block completion through 24 hours after surgery
Resting Numeric Rating Scale Pain Scores
Lasso di tempo: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain).
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Numeric Rating Scale Pain Scores With Movement
Lasso di tempo: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Pain intensity during standardized shoulder-related movement will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain), when clinically feasible.
On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
Anterior Shoulder Numeric Rating Scale Pain Score
Lasso di tempo: At 8, 12, and 24 hours after surgery
Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
At 8, 12, and 24 hours after surgery
Posterior Shoulder Numeric Rating Scale Pain Score
Lasso di tempo: At 8, 12, and 24 hours after surgery
Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
At 8, 12, and 24 hours after surgery
Proportion of Participants With Hemidiaphragmatic Paresis
Lasso di tempo: 30 minutes after block completion
Diaphragmatic excursion will be assessed using M-mode ultrasonography. Hemidiaphragmatic paresis will be defined as diaphragmatic excursion 30 minutes after block completion falling to less than 25% of the participant's baseline excursion.
30 minutes after block completion
Change in Diaphragmatic Excursion From Baseline
Lasso di tempo: Baseline and 30 minutes after block completion
Diaphragmatic excursion will be measured using M-mode ultrasonography as the difference in diaphragm position between resting expiration and deep inspiration. Three measurements will be obtained and averaged. Change from baseline will be evaluated after the block.
Baseline and 30 minutes after block completion
Shoulder Abduction Motor Strength
Lasso di tempo: Baseline, 30 minutes after block completion, and 24 hours after surgery
Shoulder abduction strength will be evaluated using the Medical Research Council (MRC) scale ranging from 0 to 5, with higher scores indicating greater muscle strength.
Baseline, 30 minutes after block completion, and 24 hours after surgery
Proportion of Participants With Rebound Pain
Lasso di tempo: During the first 24 postoperative hours
Rebound pain will be defined as an increase from an NRS pain score of 3 or lower at the preceding assessment to an NRS score of 7 or higher at the subsequent assessment.
During the first 24 postoperative hours
Quality of Recovery-15 Score
Lasso di tempo: 24 hours after surgery
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
24 hours after surgery
Patient Satisfaction With Perioperative Analgesia
Lasso di tempo: 24 hours after surgery
Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied).
24 hours after surgery
Number of Participants With Block-Related Complications
Lasso di tempo: From block performance through postoperative day 7
Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications.
From block performance through postoperative day 7
Block Performance Time
Lasso di tempo: Periprocedural
Time required to perform the allocated regional anesthesia technique, measured in seconds from the first contact of the ultrasound transducer with the skin until removal of the block needle after completion of local anesthetic injection.
Periprocedural

Collaboratori e investigatori

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

Sponsor

Izmir City Hospital

Investigatori

  • Investigatore principale: Murat KAYKAC, MD, İzmir City Hospital
  • Direttore dello studio: Derya ARSLAN YURTLU, Professor, İzmir City Hospital

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 novembre 2026

Completamento primario (Stimato)

31 maggio 2027

Completamento dello studio (Stimato)

15 giugno 2027

Date di iscrizione allo studio

Primo inviato

9 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 agosto 2026

Primo Inserito (Effettivo)

13 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SPENG-RCT-2026-01

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the principal investigator. Data will be shared after publication of the main study results, subject to approval of the proposed use and compliance with applicable ethical and institutional data-protection requirements.

Periodo di condivisione IPD

Beginning after publication of the primary study results and available for 5 years thereafter.

Criteri di accesso alla condivisione IPD

Requests from qualified researchers with a scientifically sound proposal will be considered by the principal investigator. Data will be provided in de-identified form for approved research purposes and subject to applicable institutional and ethical requirements.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • CODICE_ANALITICO

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 .

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