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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
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.
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
Fırat University Faculty of Medicine Hospital
Elâzığ, Elâzığ, Turkey (Türkiye)
Total postoperative morphine consumption during the first 24 hours after surgery
Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
Time frame: 24 hours after surgery
Intraoperative remifentanil consumption
Total intraoperative remifentanil consumption recorded in micrograms (µg) from induction of anesthesia until completion of surgery.
Time frame: From induction of anesthesia until the end of surgery
Postoperative pain intensity
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.
Time frame: From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
Time to first rescue analgesic request
Time from arrival in the post-anesthesia care unit (PACU) until the first administration of rescue analgesia, measured in minutes.
Time frame: Within 24 hours after surgery
Length of hospital stay
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.
Time frame: From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
Postoperative seizure incidence
Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
Time frame: Within 24 hours after surgery
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