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

7. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Ultrasound-guided intermediate cervical plexus block
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
Medicin: Bupivacaine
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
Placebo komparator: 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.
Procedure: Ultrasound-guided intermediate cervical plexus block
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
Medicin: Sodium Chloride 0.9% in 10 ml injection
10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total postoperative morphine consumption during the first 24 hours after surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative remifentanil consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Within 24 hours after surgery
Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
Within 24 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Firat University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2022

Primær færdiggørelse (Faktiske)

1. maj 2023

Studieafslutning (Faktiske)

31. maj 2023

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7996

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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