Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery
NCT ID: NCT04585126
Last Updated: 2020-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2019-11-28
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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General anesthesia without intermediate cervical block
General anesthesia performed by the anesthesiologist
No interventions assigned to this group
General anesthesia with intermediate cervical block
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 %)
Intermediate cervical block
Local anesthesia performed in addition to the general anesthesia
Interventions
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Intermediate cervical block
Local anesthesia performed in addition to the general anesthesia
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Centre Francois Baclesse
OTHER
University Hospital, Caen
OTHER
Responsible Party
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Principal Investigators
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Emmanuel Babin
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
Locations
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Caen University Hospital
Caen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-105
Identifier Type: -
Identifier Source: org_study_id
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