- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
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
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Elâzığ
-
Elâzığ, Elâzığ, Turkiet (Türkiye), 23100
- Fırat University Faculty of Medicine Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
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
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
Sponsor
Utredare
- Huvudutredare: Ahmet Aksu, Assistant Professor, Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Postoperativa komplikationer
- Patologiska processer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Läkemedelsresistent epilepsi
- Smärta, postoperativt
- Epilepsi
- Organiska kemikalier
- Terapeutik
- Drogadministrationsvägar
- Narkotikabehandling
- Anilider
- Amider
- Anilinföreningar
- Aminer
- Oorganiska kemikalier
- Klorföreningar
- Natriumföreningar
- Klorider
- Saltsyra
- Bupivakain
- Injektion
- Natriumklorid
Andra studie-ID-nummer
- 7996
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .