Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery

Study Overview
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Brief Summary
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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

Official Title
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Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study

Conditions
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Thyroid Surgery

Intervention / Treatment
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* Drug: Intermediate cervical block


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: General anesthesia without intermediate cervical block<br>General anesthesia performed by the anesthesiologist | |
| Active Comparator: General anesthesia with intermediate cervical block<br>General anesthesia performed by the anesthesiologist associated with an echoguided intermediate cervical block (bilateral in total thyroidectomy, unilateral in partial thyroidectomy) : 10 to 30cc of ropivacaine (2 to 3,75 %) | Drug: Intermediate cervical block<br>* Local anesthesia performed in addition to the general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on recurrent laryngeal nerve monitoring | Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring | Before surgical dissection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery | Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion) | 7 days post surgery | 
| Postoperative pain | Numerical rating pain scale (0 = no pain to 10 = worst pain) | First 24 hours post surgery | 
| Early postoperative complications | Number of patients with hypocalcemia, hematoma, nausea, vomiting | First 24 hours post surgery | 
| Postoperative dysphonia | Number of patients with post-operative dysphonia | During the first 24 hours and 7 days post surgery | 
| Late postoperative complications | Number of patients with persistent laryngeal nerve paralysis and/or dysphonia, persistent hypocalcemia, rehospitalization, revision surgery | 1 to 3 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery