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

12 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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.
Andere namen:
  • SPENG Block
Actieve vergelijker: 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.
Procedure: 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.
Andere namen:
  • Posterior Shoulder Block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants With Complete Dual-Target Sensory Block Success
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Izmir City Hospital

Onderzoekers

  • Hoofdonderzoeker: Murat KAYKAC, MD, İzmir City Hospital
  • Studie directeur: Derya ARSLAN YURTLU, Professor, İzmir City Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

31 mei 2027

Studie voltooiing (Geschat)

15 juni 2027

Studieregistratiedata

Eerst ingediend

9 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 augustus 2026

Eerst geplaatst (Werkelijk)

13 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SPENG-RCT-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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