Thyroid Surgery
Conditions
Keywords
thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery
Brief 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
Interventions
DRUGIntermediate cervical block
Local anesthesia performed in addition to the general anesthesia
Sponsors
Centre Francois Baclesse
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group
Intervention model description
Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on recurrent laryngeal nerve monitoring | Before surgical dissection | Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recovery | 7 days post surgery | Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion) |
| Postoperative pain | First 24 hours post surgery | Numerical rating pain scale (0 = no pain to 10 = worst pain) |
| Early postoperative complications | First 24 hours post surgery | Number of patients with hypocalcemia, hematoma, nausea, vomiting |
| Postoperative dysphonia | During the first 24 hours and 7 days post surgery | Number of patients with post-operative dysphonia |
| Late postoperative complications | 1 to 3 months post surgery | Number of patients with persistent laryngeal nerve paralysis and/or dysphonia, persistent hypocalcemia, rehospitalization, revision surgery |
Countries
France
Contacts
Primary ContactGulbhar AL ISSA
Outcome results
None listed