SPENG Block Versus Suprascapular and Axillary Nerve Blocks for Pain After Shoulder Arthroscopy (SPENG-RCT)
2026. augusztus 12. frissítette: 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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
60
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Murat KAYKAC, MD
- Telefonszám: +905330258450
- E-mail: drmuratkaykac@gmail.com
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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.
Más nevek:
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Aktív összehasonlító: 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.
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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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Highest Resting Numeric Rating Scale Pain Score During the First 24 Postoperative Hours
Időkeret: From arrival in the post-anesthesia care unit through 24 hours after surgery
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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.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Proportion of Participants With Complete Dual-Target Sensory Block Success
Időkeret: 30 minutes after block completion
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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.
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30 minutes after block completion
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Cumulative Opioid Consumption During the First 24 Postoperative Hours
Időkeret: From arrival in the post-anesthesia care unit through 24 hours after surgery
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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.
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From arrival in the post-anesthesia care unit through 24 hours after surgery
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Time to First Rescue Analgesic
Időkeret: From block completion through 24 hours after surgery
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Time from completion of the study block to the first administration of rescue analgesic medication for postoperative pain.
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From block completion through 24 hours after surgery
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Resting Numeric Rating Scale Pain Scores
Időkeret: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Resting pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 (no pain) to 10 (worst imaginable pain).
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On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Numeric Rating Scale Pain Scores With Movement
Időkeret: On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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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.
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On arrival in the post-anesthesia care unit and at 4, 8, 12, and 24 hours after surgery
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Anterior Shoulder Numeric Rating Scale Pain Score
Időkeret: At 8, 12, and 24 hours after surgery
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Pain localized predominantly to the anterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
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Posterior Shoulder Numeric Rating Scale Pain Score
Időkeret: At 8, 12, and 24 hours after surgery
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Pain localized predominantly to the posterior shoulder will be rated separately using an 11-point Numeric Rating Scale ranging from 0 to 10.
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At 8, 12, and 24 hours after surgery
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Proportion of Participants With Hemidiaphragmatic Paresis
Időkeret: 30 minutes after block completion
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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.
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30 minutes after block completion
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Change in Diaphragmatic Excursion From Baseline
Időkeret: Baseline and 30 minutes after block completion
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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.
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Baseline and 30 minutes after block completion
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Shoulder Abduction Motor Strength
Időkeret: Baseline, 30 minutes after block completion, and 24 hours after surgery
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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.
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Baseline, 30 minutes after block completion, and 24 hours after surgery
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Proportion of Participants With Rebound Pain
Időkeret: During the first 24 postoperative hours
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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.
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During the first 24 postoperative hours
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Quality of Recovery-15 Score
Időkeret: 24 hours after surgery
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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.
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24 hours after surgery
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Patient Satisfaction With Perioperative Analgesia
Időkeret: 24 hours after surgery
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Overall satisfaction with perioperative analgesia will be rated on an 11-point scale from 0 (completely dissatisfied) to 10 (completely satisfied).
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24 hours after surgery
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Number of Participants With Block-Related Complications
Időkeret: From block performance through postoperative day 7
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Participants will be assessed for block-related adverse events including hematoma, infection, persistent paresthesia, persistent weakness, and other clinically suspected complications.
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From block performance through postoperative day 7
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Block Performance Time
Időkeret: Periprocedural
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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.
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Periprocedural
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Murat KAYKAC, MD, İzmir City Hospital
- Tanulmányi igazgató: Derya ARSLAN YURTLU, Professor, İzmir City Hospital
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. november 1.
Elsődleges befejezés (Becsült)
2027. május 31.
A tanulmány befejezése (Becsült)
2027. június 15.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. augusztus 9.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 9.
Első közzététel (Tényleges)
2026. augusztus 13.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. augusztus 14.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 12.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SPENG-RCT-2026-01
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
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 megosztási időkeret
Beginning after publication of the primary study results and available for 5 years thereafter.
IPD-megosztási hozzáférési feltételek
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.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ANALYTIC_CODE
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
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