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

7 juli 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
Placebo-jämförare: 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.
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total postoperative morphine consumption during the first 24 hours after surgery
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intraoperative remifentanil consumption
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Within 24 hours after surgery
Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
Within 24 hours after surgery

Samarbetspartners och utredare

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Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2022

Primärt slutförande (Faktisk)

1 maj 2023

Avslutad studie (Faktisk)

31 maj 2023

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

8 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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