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NCT Number: NCT07689617

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

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.

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Key information

Conditions

Drug-resistant Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vagus Nerve Stimulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fırat University Faculty of Medicine Hospital

Elâzığ, 23100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided intermediate cervical plexus block

Procedure

Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.

Sodium Chloride 0.9% in 10 ml injection

Drug

10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.

Bupivacaine

Drug

10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.

Primary outcomes

  1. Total postoperative morphine consumption during the first 24 hours after surgery

    Time frame: 24 hours after surgery

    Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).

Secondary outcomes

  1. Intraoperative remifentanil consumption

    Time frame: 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.

  2. Postoperative pain intensity

    Time frame: 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.

  3. Time to first rescue analgesic request

    Time frame: 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.

  4. Length of hospital stay

    Time frame: 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.

  5. Postoperative seizure incidence

    Time frame: Within 24 hours after surgery

    Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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