Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery (NCT04585126) | Clinical Trial Compass
UnknownNot Applicable
Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery
France120 participantsStarted 2019-11-28
Plain-language summary
Non-inferiority study aimed to assess the impact of cervical block on recurrent laryngeal nerve monitoring during thyroid surgery Secondary outcomes will assess post-operative recovery, post-operative pain and post-operative dysphonia
Who can participate
Age range
18 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:
* Patients over 18, able to give consent after clear and fair information
* Affiliated to social security
* Total thyroidectomy performed in the context of Graves' disease in biological euthyroidism with the need for surgical treatment (pregnancy project, fluctuating TSH, etc.), or multiheteronodular goiter with suspect or compressive nodules, or lobo-isthmectomy
* No previous homolateral cervical surgery
* Professional activity
* Telephone line (at home or cellular)
Exclusion Criteria:
* Patients over 18 under legal protection
* Allergy to local anesthetics
* Existence of preoperative laryngeal dysphonia or paralysis
* Patient with a submerging goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
* Presence of uncontrolled infectious pathology
* Pregnant or breastfeeding woman or no contraception
* Lymph node dissection planned or patient at high risk of lymph node dissection (BETHESDA 5 and 6)
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.
1This trial is looking at how a cervical nerve block affects the monitoring of the recurrent laryngeal nerve during thyroid surgery — can you explain what recurrent laryngeal nerve monitoring is and why it matters for my specific surgery?
2Since this trial has an unknown recruitment status, is it still actively enrolling patients, and would it even be an option worth pursuing for me right now?
3The study focuses on a cervical block as part of anesthesia or pain management during thyroid surgery — how does this compare to the standard approach you would normally use for my procedure, and what are the potential risks of the block itself?
4If the cervical block were to interfere with nerve monitoring signals during my surgery, what safeguards would be in place to protect my recurrent laryngeal nerve and reduce the risk of voice or swallowing problems afterward?
5Given that this trial is listed as phase 'NA' — meaning it may be more of a procedural or device study than a drug trial — what does that mean for how much is already known about the safety and effectiveness of this approach?
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.