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Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery

7 juillet 2026 mis à jour par: AHMET AKSU, Firat University

Effects of Ultrasound-Guided Intermediate Cervical Plexus Block on Postoperative Analgesia and Opioid Consumption in Vagus Nerve Stimulation Surgery: A Prospective Randomized Controlled Trial

This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the analgesic efficacy of ultrasound-guided intermediate cervical plexus block (ICB) in patients undergoing vagus nerve stimulation (VNS) implantation surgery under general anesthesia. Participants are randomly assigned to receive either an ultrasound-guided ICB with 10 mL of 0.25% bupivacaine or a placebo injection with 10 mL of normal saline following induction of general anesthesia. The primary outcome is total postoperative morphine consumption during the first 24 hours after surgery. Secondary outcomes include intraoperative remifentanil consumption, postoperative pain intensity assessed using the Numeric Rating Scale (NRS), time to first analgesic request, length of hospital stay, and postoperative seizure incidence.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Postoperative pain following vagus nerve stimulation (VNS) implantation surgery originates from both cervical and infraclavicular surgical incisions. Although opioid analgesics are commonly used for postoperative pain control, minimizing opioid exposure is particularly desirable in patients with drug-resistant epilepsy because opioid-related adverse effects may delay recovery and potentially influence neurological assessment.

The intermediate cervical plexus block (ICB) is an ultrasound-guided regional anesthesia technique that provides sensory blockade of the superficial branches of the cervical plexus while allowing accurate deposition of local anesthetic between the investing and prevertebral layers of the deep cervical fascia. Previous studies have demonstrated the effectiveness of cervical plexus blocks in various cervical surgical procedures; however, evidence regarding their use during VNS implantation surgery remains limited.

This prospective, randomized, double-blind, placebo-controlled study compares ultrasound-guided ICB using 10 mL of 0.25% bupivacaine with a placebo injection of 10 mL normal saline administered after induction of general anesthesia. The primary objective is to determine whether ICB reduces postoperative opioid requirements during the first 24 hours after surgery. Secondary objectives include evaluation of intraoperative remifentanil consumption, postoperative pain scores, time to first rescue analgesic, length of hospital stay, and postoperative seizure incidence. The findings are expected to provide evidence regarding the effectiveness and safety of ultrasound-guided intermediate cervical plexus block as part of multimodal analgesia for patients undergoing VNS implantation surgery.

Type d'étude

Interventionnel

Inscription (Réel)

52

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

  • Turquie (Türkiye)
    • Elâzığ
      • Elâzığ, Elâzığ, Turquie (Türkiye), 23100
        • Fırat University Faculty of Medicine Hospital

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

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults aged 18-60 years
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Drug-resistant epilepsy
  • Scheduled for elective vagus nerve stimulation implantation surgery under general anesthesia
  • Written informed consent obtained

Exclusion Criteria:

  • Allergy or contraindication to local anesthetics
  • Coagulopathy or current anticoagulant therapy
  • Infection at the injection site
  • Pregnancy or breastfeeding
  • Severe pulmonary disease
  • Inability to understand or use the Numeric Rating Scale (NRS)
  • Refusal to participate

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intermediate Cervical Plexus Block
Participants received an ultrasound-guided intermediate cervical plexus block with 10 mL of 0.25% bupivacaine after induction of general anesthesia before vagus nerve stimulation implantation surgery.
Procédure: Ultrasound-guided intermediate cervical plexus block
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
Médicament: Bupivacaine
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
Comparateur placebo: Control
Participants received an ultrasound-guided placebo injection with 10 mL of 0.9% normal saline after induction of general anesthesia before vagus nerve stimulation implantation surgery.
Procédure: Ultrasound-guided intermediate cervical plexus block
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
Médicament: Sodium Chloride 0.9% in 10 ml injection
10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Total postoperative morphine consumption during the first 24 hours after surgery
Délai: 24 hours after surgery
Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
24 hours after surgery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Intraoperative remifentanil consumption
Délai: From induction of anesthesia until the end of surgery
Total intraoperative remifentanil consumption recorded in micrograms (µg) from induction of anesthesia until completion of surgery.
From induction of anesthesia until the end of surgery
Postoperative pain intensity
Délai: From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
Pain intensity was assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at PACU admission, 30 minutes after PACU admission, and at postoperative 1, 6, 12, and 24 hours.
From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
Time to first rescue analgesic request
Délai: Within 24 hours after surgery
Time from arrival in the post-anesthesia care unit (PACU) until the first administration of rescue analgesia, measured in minutes.
Within 24 hours after surgery
Length of hospital stay
Délai: From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
Time to first rescue analgesic request was defined as the time from PACU arrival to the first request or administration of rescue analgesia. Patients who did not require rescue analgesia within 24 hours were censored at 24 hours.
From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
Postoperative seizure incidence
Délai: Within 24 hours after surgery
Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
Within 24 hours after surgery

Collaborateurs et enquêteurs

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

Parrainer

Firat University

Les enquêteurs

  • Chercheur principal: Ahmet Aksu, Assistant Professor, Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation

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 (Réel)

1 mai 2022

Achèvement primaire (Réel)

1 mai 2023

Achèvement de l'étude (Réel)

31 mai 2023

Dates d'inscription aux études

Première soumission

30 juin 2026

Première soumission répondant aux critères de contrôle qualité

7 juillet 2026

Première publication (Réel)

8 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7996

Plan pour les données individuelles des participants (IPD)

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

NON

Description du régime IPD

De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, following publication, subject to institutional approval and applicable ethical and legal requirements.

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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