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

NCT04585126 | Unknown

• 1 other identifier: 19-105
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Thyroid Surgery

Keywords

thyroid surgery; cervical nerve block; recurrent laryngeal nerve monitoring; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Effect on recurrent laryngeal nerve monitoring

  Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring

  Before surgical dissection

Secondary Outcomes (5)

• Postoperative recovery

  7 days post surgery

• Postoperative pain

  First 24 hours post surgery

• Early postoperative complications

  First 24 hours post surgery

• Postoperative dysphonia

  During the first 24 hours and 7 days post surgery

• Late postoperative complications

  1 to 3 months post surgery

Study Arms (2)

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 %)

Drug: Intermediate cervical block

Interventions

Intermediate cervical block DRUG

Local anesthesia performed in addition to the general anesthesia

General anesthesia with intermediate cervical block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Caen: lead
• Centre Francois Baclesse: collaborator

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

Study Officials

• Emmanuel Babin

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulbhar AL ISSA

CONTACT

+33678548573; g.alissa89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: November 28, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

FR (1)