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Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia

23 mai 2026 mis à jour par: Hongwei Shi, Nanjing First Hospital, Nanjing Medical University

Effect of Liposomal Bupivacaine and Bupivacaine Hydrochloride for Superior Trunk Block of the Interscalene Brachial Plexus on Postoperative Diaphragmatic Function and Analgesia in Shoulder Surgery: A Multicenter, Randomized Controlled Study

To compare the effects of 1.33% liposomal bupivacaine versus 0.375% bupivacaine hydrochloride for superior trunk block of the interscalene brachial plexus on postoperative diaphragmatic function and analgesic efficacy in shoulder surgery.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

184

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, Chine
        • Nanjing Gaochun People's Hospital
      • Suzhou, Jiangsu, Chine
        • The First Affiliated Hospital of Soochow University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Patients scheduled for elective unilateral proximal humerus surgery, rotator cuff surgery, shoulder arthroplasty, or shoulder arthroscopy;
  • Visible diaphragmatic movement on the surgical side under ultrasound before anesthesia;
  • Patient provides informed consent;
  • Age 18-80 years, any gender;
  • ASA physical status I-III;
  • 18 kg/m² ≤ BMI ≤ 30 kg/m².

Exclusion Criteria:

  • Coagulopathy;
  • Allergy to local anesthetics;
  • Infection at the puncture site;
  • History of chronic pain or opioid use;
  • Severe respiratory disease;
  • Pregnancy;
  • Diabetes and peripheral neuropathy;
  • Inability to understand assessment scales.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Liposomal Bupivacaine
When performing a superior trunk block of the interscalene brachial plexus, the local anesthetic used is 1.33% liposomal bupivacaine.
Médicament: Liposomal bupivacaine
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 1.33% Liposomal bupivacaine 10ml was injected.
Comparateur actif: Bupivacaine Hydrochloride
When performing the superior trunk block of the interscalene brachial plexus, 0.375% bupivacaine hydrochloride is used as the local anesthetic.
Médicament: Bupivacaine Hydrochloride
The superior trunk was visualized distal to the convergence of the C5 and C6 nerve roots but proximal to the take-off of the suprascapular nerve. The block needle was advanced in-plane to the ultrasound beam in a lateral-to-medial direction under the deep cervical fascia and superficial to the middle scalene muscle, until the needle tip was immediately adjacent to the lateral border of the superior trunk. 0.375% Bupivacaine Hydrochloride 10ml was injected.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The incidence of hemi-diaphragmatic paralysis( Partial plus complete diaphragmatic paralysis) after superior trunk block of the interscalene brachial plexus
Délai: Before block 、before leaving the PACU after surgery and 24 hours after surgery
Observe diaphragmatic movement through the hepatic or splenic acoustic window and measure the amplitude of diaphragmatic excursion on the anesthetized side using M-mode (average of 3 waveforms). Diaphragmatic Function Evaluation[4,5]: A decrease in diaphragmatic excursion amplitude during deep breathing of <25% compared to pre-block is defined as normal diaphragmatic movement. A decrease of 25%-75% is defined as partial diaphragmatic paralysis. A decrease of >75% is defined as complete diaphragmatic paralysis.
Before block 、before leaving the PACU after surgery and 24 hours after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Numeric Rating Scale (NRS) scores during activity and at rest
Délai: Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
Pain intensity at the surgical site will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Patients will self-report their pain intensity at rest (Resting NRS) and during active movement (Dynamic NRS)
Postoperative 30 minutes, 1 hour, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, and 72 hours
The area under the pain intensity-time curve (PI-AUC)
Délai: Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
The Pain Intensity-Area Under the Curve (PI-AUC) will be calculated as a summary measure of overall pain burden over time. The AUC for each patient will be computed for three consecutive postoperative periods based on the serial NRS scores (both resting and dynamic) collected during those intervals. A smaller AUC indicates better overall analgesic control during the specified period.
Postoperative periods (0-24 hours, 24-48 hours, 48-72 hours)
Postoperative recovery quality (QoR-15 score)
Délai: Postoperative days 1, 2, and 3
Patient-reported recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. This validated tool evaluates physical comfort, physical independence, psychological support, emotional state, and pain. Scores range from 0 (extremely poor recovery) to 150 (excellent recovery). The upward trend of the QoR-15 score signifies a progressive and comprehensive improvement in a patient's postoperative recovery experience across physical, emotional, and functional domains.
Postoperative days 1, 2, and 3
Analgesia satisfaction (OBAS score)
Délai: Postoperative days 1, 2, and 3
Patient satisfaction with analgesia and its associated side effects will be evaluated using the Overall Benefit of Analgesia Score (OBAS). The OBAS is a composite score (range 0-28, lower is better) incorporating assessments of pain intensity, nausea/vomiting, dizziness, sedation, itching, and patient satisfaction. The downward trend of the OBAS score indicates a progressively more favorable balance between analgesic efficacy and the burden of treatment-related side effects, representing an increasing net benefit of the analgesia regimen.
Postoperative days 1, 2, and 3
Morphine equivalent consumption
Délai: Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The total consumption of all opioid analgesics administered to the patient (including patient-controlled analgesia and rescue doses). All opioid doses will be converted to intravenous morphine milligram equivalents (MME) using standard conversion ratios for summation and comparison. A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
Postoperative periods of 0-24 hours, 24-48 hours, and 48-72 hours
The cumulative dosage of rescue analgesic medication (calculated as morphine equivalent in mg)
Délai: 0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
This refers specifically to the summed dose of supplemental (rescue) opioid analgesics administered upon patient request for breakthrough pain. The cumulative dose for each period will be calculated and expressed in intravenous morphine milligram equivalents (MME). A lower morphine equivalent consumption indicates better analgesic efficacy and a longer duration of action for liposomal bupivacaine.
0-24 hours, 24-48 hours, and 48-72 hours after the first postoperative administration.
Telephone follow-up for pain NRS score
Délai: Postoperative 3 months
Patients will be contacted by telephone at 3 months after surgery. They will be asked to self-report their current average pain intensity over the past 24 hours at the surgical site using the 11-point Numeric Rating Scale (NRS, 0-10), where 0 represents "no pain" and 10 represents "the worst pain imaginable." This assesses the potential long-term impact of the analgesic intervention on persistent postoperative pain.
Postoperative 3 months
Incidence of adverse events: Vascular injury, hoarseness, Horner's syndrome, SpO2 below 90% without oxygen supplementation after leaving PACU, dyspnea, numbness of fingers, dyskinesia.
Délai: Postoperative 72 hours

Vascular injury: Evidence of hematoma or vascular puncture during needle placement.

Hoarseness: Patient-reported or clinician-identified voice change suggestive of recurrent laryngeal nerve involvement.

Horner's syndrome: Presence of ptosis, miosis, and/or anhidrosis on the blocked side.

Diaphragmatic paralysis: defined by a reduction in diaphragmatic excursion amplitude >25% from baseline on ultrasound assessment performed post-block.

SpO2 <90% on room air after PACU discharge: Oxygen saturation falling below 90% while breathing room air, occurring after the patient has been discharged from the PACU, and not related to other obvious causes.

Dyspnea: Subjective sensation of shortness of breath or labored breathing. Finger numbness: Persistent numbness or loss of sensation in the fingers of the blocked upper limb.

Motor difficulty: Persistent weakness or inability to perform specific voluntary movements in the blocked upper limb.
Postoperative 72 hours

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nanjing First Hospital, Nanjing Medical University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

6 mai 2026

Achèvement primaire (Estimé)

31 mars 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

5 mai 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY20260402-03

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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