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

Thyroid Surgery Clinical Trial

— THYRODOUL2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585126
• Other study ID #: 19-105
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: November 2021

Study information

• Verified date: October 2020
• Source: University Hospital, Caen
• Contact: Gulbhar AL ISSA
• Phone: +33678548573
• Email: g.alissa89[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Surgery

Intervention

Drug:
• Intermediate cervical block
Local anesthesia performed in addition to the general anesthesia

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on recurrent laryngeal nerve monitoring	Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring	Before surgical dissection
Secondary	Postoperative recovery	Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion)	7 days post surgery
Secondary	Postoperative pain	Numerical rating pain scale (0 = no pain to 10 = worst pain)	First 24 hours post surgery
Secondary	Early postoperative complications	Number of patients with hypocalcemia, hematoma, nausea, vomiting	First 24 hours post surgery
Secondary	Postoperative dysphonia	Number of patients with post-operative dysphonia	During the first 24 hours and 7 days post surgery
Secondary	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