Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve S… (NCT07689617) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery
Turkey (Türkiye)52 participantsStarted 2022-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total postoperative morphine consumption during the first 24 hours after surgery