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

NCT ID: NCT04585126

Last Updated: 2020-10-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2021-11-30

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

Detailed Description

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Conditions

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Thyroid Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group

Study Groups

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General anesthesia without intermediate cervical block

General anesthesia performed by the anesthesiologist

Group Type NO_INTERVENTION

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 %)

Group Type ACTIVE_COMPARATOR

Intermediate cervical block

Intervention Type DRUG

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

Intervention Type DRUG

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Babin

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gulbhar AL ISSA

Role: CONTACT

+33678548573

Facility Contacts

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Gulbhar AL ISSA

Role: primary

+33678548573

Other Identifiers

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19-105

Identifier Type: -

Identifier Source: org_study_id

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