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| Name | Class |
|---|---|
| Centre Francois Baclesse | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia without intermediate cervical block | No Intervention | General anesthesia performed by the anesthesiologist | |
| General anesthesia with intermediate cervical block | Active Comparator | 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 %) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermediate cervical block | Drug | Local anesthesia performed in addition to the general anesthesia |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gulbhar AL ISSA | Contact | +33678548573 | g.alissa89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Babin | University Hospital, Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | 14000 | France |
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Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
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Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group
| 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 |