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- Sperimentazione clinica NCT07689617
Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery
Effects of Ultrasound-Guided Intermediate Cervical Plexus Block on Postoperative Analgesia and Opioid Consumption in Vagus Nerve Stimulation Surgery: A Prospective Randomized Controlled Trial
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Elâzığ
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Elâzığ, Elâzığ, Turchia (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Comparatore 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total postoperative morphine consumption during the first 24 hours after surgery
Lasso di tempo: 24 hours after surgery
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Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
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24 hours after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intraoperative remifentanil consumption
Lasso di tempo: From induction of anesthesia until the end of surgery
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Total intraoperative remifentanil consumption recorded in micrograms (µg) from induction of anesthesia until completion of surgery.
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From induction of anesthesia until the end of surgery
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Postoperative pain intensity
Lasso di tempo: From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
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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.
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From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
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Time to first rescue analgesic request
Lasso di tempo: Within 24 hours after surgery
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Time from arrival in the post-anesthesia care unit (PACU) until the first administration of rescue analgesia, measured in minutes.
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Within 24 hours after surgery
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Length of hospital stay
Lasso di tempo: From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
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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.
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From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
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Postoperative seizure incidence
Lasso di tempo: Within 24 hours after surgery
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Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
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Within 24 hours after surgery
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ahmet Aksu, Assistant Professor, Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Complicanze postoperatorie
- Processi patologici
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Epilessia resistente ai farmaci
- Dolore, Postoperatorio
- Epilessia
- Prodotti chimici organici
- Terapie
- Rotte della somministrazione di droga
- Terapia farmacologica
- Anilides
- Amides
- Composti di anilina
- Ammine
- Prodotti chimici inorganici
- Composti di cloro
- Composti di sodio
- Cloruri
- Acido cloridrico
- Bupivacaina
- Iniezioni
- Cloruro di sodio
Altri numeri di identificazione dello studio
- 7996
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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