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

Primary Purpose

Thyroid Surgery

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intermediate cervical block
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thyroid Surgery focused on measuring thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

General anesthesia without intermediate cervical block

General anesthesia with intermediate cervical block

Arm Description

General anesthesia performed by the anesthesiologist

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 %)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative recovery
Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion)
Postoperative pain
Numerical rating pain scale (0 = no pain to 10 = worst pain)
Early postoperative complications
Number of patients with hypocalcemia, hematoma, nausea, vomiting
Postoperative dysphonia
Number of patients with post-operative dysphonia
Late postoperative complications
Number of patients with persistent laryngeal nerve paralysis and/or dysphonia, persistent hypocalcemia, rehospitalization, revision surgery

Full Information

First Posted
October 2, 2020
Last Updated
October 12, 2020
Sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04585126
Brief Title
Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery
Acronym
THYRODOUL2
Official Title
Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Surgery
Keywords
thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, surgeons and outcomes assessor are blind Only the anesthesiologist taking care of the patient knows the allocation group
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia without intermediate cervical block
Arm Type
No Intervention
Arm Description
General anesthesia performed by the anesthesiologist
Arm Title
General anesthesia with intermediate cervical block
Arm Type
Active Comparator
Arm Description
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 %)
Intervention Type
Drug
Intervention Name(s)
Intermediate cervical block
Intervention Description
Local anesthesia performed in addition to the general anesthesia
Primary Outcome Measure Information:
Title
Effect on recurrent laryngeal nerve monitoring
Description
Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring
Time Frame
Before surgical dissection
Secondary Outcome Measure Information:
Title
Postoperative recovery
Description
Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion)
Time Frame
7 days post surgery
Title
Postoperative pain
Description
Numerical rating pain scale (0 = no pain to 10 = worst pain)
Time Frame
First 24 hours post surgery
Title
Early postoperative complications
Description
Number of patients with hypocalcemia, hematoma, nausea, vomiting
Time Frame
First 24 hours post surgery
Title
Postoperative dysphonia
Description
Number of patients with post-operative dysphonia
Time Frame
During the first 24 hours and 7 days post surgery
Title
Late postoperative complications
Description
Number of patients with persistent laryngeal nerve paralysis and/or dysphonia, persistent hypocalcemia, rehospitalization, revision surgery
Time Frame
1 to 3 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gulbhar AL ISSA
Phone
+33678548573
Email
g.alissa89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Babin
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulbhar AL ISSA
Phone
+33678548573
Email
g.alissa89@gmail.com

12. IPD Sharing Statement

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

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