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Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery

22. juni 2026 oppdatert av: Mahdy Mohamed Elghanam, Menoufia University

Shoulder surgery causes significant postoperative pain, and ultrasound-guided regional anesthesia is central to its management. The interscalene block (ISB) is the gold standard but frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis, limiting its use in patients with reduced pulmonary reserve. The suprascapular (SSNB) and costoclavicular (CCB) blocks are proposed diaphragm-sparing alternatives, but data directly comparing all three are limited.

This randomised, double-blinded trial will compare the incidence of hemi-diaphragmatic paresis among ultrasound-guided ISB, SSNB, and CCB in elective shoulder surgery. Seventy-five ASA I-II patients aged 18-70 will be allocated 1:1:1 to one block. The primary outcome is the incidence of hemi-diaphragmatic paresis, measured by ultrasound diaphragmatic excursion before induction and after recovery in the PACU. Secondary outcomes include postoperative pain, analgesic consumption, and patient satisfaction. The investigators hypothesise that SSNB and CCB will cause less hemidiaphragmatic paresis than ISB while providing comparable analgesia.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This randomized, double-blinded, parallel-group trial compares the effect of three ultrasound-guided regional anesthesia techniques on diaphragmatic function in elective shoulder surgery. The interscalene block (ISB), the gold standard, frequently causes phrenic nerve paralysis and hemi-diaphragmatic paresis. The suprascapular (SSNB) and costoclavicular (CCB) blocks preserve analgesia while sparing the phrenic nerve, but direct comparative data among all three are limited.

Seventy-five ASA I-II patients aged 18-70 scheduled for elective shoulder surgery will be randomized 1:1:1 (25 per group) using computer-generated allocation with sealed opaque envelopes. ISB: 10 mL 0.25% bupivacaine with dexmedetomidine 0.5 µg/kg; SSNB: 10 mL of the same mixture; CCB: 20 mL of the same mixture. All blocks are ultrasound-guided and performed before a standardised general anaesthetic.

Diaphragmatic excursion is measured by M-mode ultrasound of both hemidiaphragms at baseline (pre-induction), 30 minutes after the block, and in the PACU at a train-of-four ratio ≥0.9. Hemi-diaphragmatic paresis is graded as Complete (>75% reduction or paradoxical movement), Partial (25-75%), or Normal (0-25%). The primary outcome is its incidence. Secondary outcomes include VAS pain at rest and movement (1, 3, 6, 12, 24 h), analgesic consumption, time to first rescue analgesia, block performance time, complications, and patient satisfaction.

Studietype

Intervensjonell

Registrering (Antatt)

75

Fase

  • Fase 4

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Adults of both sexes, aged 18 to 70 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective shoulder surgery

Exclusion Criteria:

Pulmonary disease or baseline diaphragmatic dysfunction Refusal to provide informed consent Pre-existing neuropathy in the operated limb Allergy to local anesthetics Infection at the injection site Coagulopathy Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Interscalene Block (ISB)
Ultrasound-guided interscalene brachial plexus block targeting the C5-C6 roots, performed approximately 1 hour before surgery. Injectate: 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg.
Fremgangsmåte: Ultrasound-guided interscalene brachial plexus block
Ultrasound-guided interscalene brachial plexus block performed ~1 hour before surgery. With the patient supine and head rotated contralaterally, a high-frequency linear transducer identifies the C5-C6 roots between the anterior and middle scalene muscles. Using an in-plane technique, 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected with frequent aspiration.
Eksperimentell: Suprascapular Nerve Block (SSNB)
Ultrasound-guided suprascapular nerve block was performed proximal to the transverse scapular ligament, approximately 1 hour before surgery. Injectate: 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg.
Fremgangsmåte: Ultrasound-guided suprascapular nerve block
Ultrasound-guided suprascapular nerve block performed ~1 hour before surgery. A linear high-frequency probe in the supraclavicular region identifies the suprascapular nerve. A 22-gauge echogenic needle is advanced in-plane to the nerve proximal to the transverse scapular ligament, and 10 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected under real-time ultrasound, confirming circumferential spread.
Eksperimentell: Costoclavicular Block (CCB)
Ultrasound-guided costoclavicular brachial plexus block targeting the brachial plexus cords in the costoclavicular space, approximately 1 hour before surgery. Injectate: 20 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg.
Fremgangsmåte: Ultrasound-guided costoclavicular brachial plexus block
Ultrasound-guided costoclavicular brachial plexus block performed ~1 hour before surgery. With the operative arm abducted ~60°, a linear probe inferior to the mid-clavicle visualizes the three brachial plexus cords lateral to the axillary artery. An echogenic needle is advanced in-plane into the interfascial plane, and 20 mL of 0.25% bupivacaine combined with dexmedetomidine 0.5 µg/kg is injected with aspiration and ultrasound confirmation of homogeneous spread.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of hemi-diaphragmatic paresis
Tidsramme: From pre-induction baseline to PACU assessment at train-of-four ratio ≥0.9 (up to approximately 24 hours after the block
Incidence of hemi-diaphragmatic paresis assessed by M-mode ultrasound measurement of diaphragmatic excursion, comparing post-block values to the pre-induction baseline. Hemi-diaphragmatic paresis is defined as a >75% reduction in diaphragmatic excursion from baseline or paradoxical diaphragmatic movement (complete paresis); a 25-75% reduction is classified as partial paresis. Measured in the PACU after recovery of muscle power (train-of-four ratio ≥0.9). Reported as the number/percentage of participants with hemi-diaphragmatic paresis in each group.
From pre-induction baseline to PACU assessment at train-of-four ratio ≥0.9 (up to approximately 24 hours after the block

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain score at rest (static VAS)
Tidsramme: At 1, 3, 6, 12, and 24 hours postoperatively
Pain intensity at rest was measured on a visual analogue scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
At 1, 3, 6, 12, and 24 hours postoperatively
Patient satisfaction
Tidsramme: 24 hours postoperatively
Overall satisfaction with the procedure and postoperative analgesia, assessed on a 5-point scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).
24 hours postoperatively

Samarbeidspartnere og etterforskere

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Sponsor

Menoufia University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ANESTH50 (Annen identifikator: Menoufia university)

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Nei

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