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

Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study

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

Study Overview

• Status: Unknown
• Conditions: Thyroid Surgery
• Intervention / Treatment: Drug: Intermediate cervical block

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gulbhar AL ISSA; Phone Number: +33678548573; Email: g.alissa89@gmail.com

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • CAEN University Hospital
    • Contact: Gulbhar AL ISSA; Phone Number: +33678548573; Email: g.alissa89@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: General anesthesia without intermediate cervical block; General anesthesia performed by the anesthesiologist
Active Comparator: 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 %)	Drug: Intermediate cervical block; Local anesthesia performed in addition to the general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Centre Francois Baclesse
• Investigators: Principal Investigator: Emmanuel Babin, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: enhanced recovery after surgery; thyroid surgery; cervical nerve block; recurrent laryngeal nerve monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: 19-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No