- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07936435
SPENG Block Versus Superior Trunk Block for Shoulder Surgery: Effects on Diaphragmatic Function, Mechanical Power, Nociception, and Analgesia: A Randomized Controlled Trial
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nurullah Damla, MD
- Numer telefonu: +905075482122
- E-mail: nurullahdamla@hotmail.com
Lokalizacje studiów
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Bursa
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Bursa, Bursa, Turcja (Türkiye), 16310
- University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital
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Kontakt:
- Nurullah Damla, MD
- Numer telefonu: +905075482122
- E-mail: nurullahdamla@hotmail.com
-
Główny śledczy:
- Korgün Ökmen, MD
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Pod-śledczy:
- Kamer Kılınç, MD
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Pod-śledczy:
- Nurullah Damla, MD
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Pod-śledczy:
- Furkan Sakın, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
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Aktywny 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Hemidiaphragmatic Paralysis
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Diaphragmatic Excursion
Ramy czasowe: 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
Ramy czasowe: 10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery
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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
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Intraoperative Driving Pressure and Static Compliance
Ramy czasowe: 10 minutes after intubation, after surgical positioning, at 30 and 60 minutes of surgery, and at the end of surgery
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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
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Intraoperative Nociception (qNOX)
Ramy czasowe: 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
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Intraoperative Supplemental Fentanyl Consumption
Ramy czasowe: Intraoperative period
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Total supplemental fentanyl (µg) and number of supplemental doses administered for qNOX >60 lasting longer than 1 minute. |
Intraoperative period
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Postoperative Pain Scores
Ramy czasowe: On arrival at the post-anesthesia care unit, at 30 minutes, and at 2, 4, 6, 12, and 24 hours postoperatively
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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
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Time to First Rescue Analgesic
Ramy czasowe: Postoperative 24 hours
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Time (minutes) from the end of surgery to the first administration of rescue tramadol for VAS ≥4. |
Postoperative 24 hours
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Total Rescue Tramadol Consumption
Ramy czasowe: Postoperative 24 hours
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Total intravenous tramadol (mg) administered as rescue analgesia. |
Postoperative 24 hours
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Patient Satisfaction
Ramy czasowe: Postoperative 24 hours
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Assessed with a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). |
Postoperative 24 hours
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Incidence of Block-Related Adverse Events
Ramy czasowe: Postoperative 24 hours
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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
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Block Performance Time
Ramy czasowe: During block procedure
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Total time (minutes) for ultrasound imaging and needling. |
During block procedure
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Motor Block of the Shoulder
Ramy czasowe: 20 minutes after block
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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
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Korgün Ökmen, University of Health Sciences, Bursa Yüksek İhtisas Training and Research Hospital
Publikacje i pomocne linki
Publikacje ogólne
- Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.
- Lentz B, Kharasch S, Goldsmith AJ, Brown J, Duggan NM, Nagdev A. Diaphragmatic Excursion as a Novel Objective Measure of Serratus Anterior Plane Block Efficacy: A Case Series. Clin Pract Cases Emerg Med. 2022 Nov;6(4):276-279. doi: 10.5811/cpcem.2022.7.57457.
- Ferre F, Mastantuono JM, Martin C, Ferrier A, Marty P, Laumonerie P, Bonnevialle N, Minville V. [Hemidiaphragmatic paralysis after ultrasound-guided supraclavicular block: a prospective cohort study]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):580-586. doi: 10.1016/j.bjan.2019.09.002. Epub 2019 Nov 30.
- Lee MG, Shin YJ, You HS, Lim CH, Chang YJ, Shin HJ. A Comparison of Anesthetic Quality Between Interscalene Block and Superior Trunk Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Trial. Pain Physician. 2021 May;24(3):235-242.
- Jo Y, Oh C, Lee WY, Lee D, Shin S, Chung W, Lim C, Lee SY, Hong B. Diaphragm-sparing efficacy of subparaneural upper trunk block for arthroscopic shoulder surgery: A randomised controlled trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):760-768. doi: 10.1097/EJA.0000000000002034. Epub 2024 Jul 3.
- Kilicaslan A, Kekec AF, Erdem TE, Kilic G, Aycan IO, Arici AG, Koc MN, Sobay K, Dayanan AR, Sindel M, Ozer M. Shoulder Posterior Pericapsular Nerve Group (SPENG) Block: A Novel Posterior Pericapsular Technique for Combined Suprascapular and Axillary Nerve Blockade. Pain Med. 2026 Jul 27:pnag098. doi: 10.1093/pm/pnag098. Online ahead of print. No abstract available.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BursaYIERH-AR-ND-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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