Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery (THYRODOUL2)

Caen University Hospital

Status: Unknown

Conditions: Thyroid Surgery

Treatments: Drug: Intermediate cervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT04585126

19-105

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

General anesthesia without intermediate cervical block

No Intervention group

Description:

General anesthesia performed by the anesthesiologist

General anesthesia with intermediate cervical block

Active Comparator group

Description:

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 %)

Treatment:

Drug: Intermediate cervical block