Thyroid SurgeryTHYRODOUL2NCT04585126
Effect of Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery
A study testing Intermediate cervical block in people with Thyroid Surgery, run by University Hospital, Caen at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Intermediate cervical block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Gulbhar AL ISSA, +33678548573, g.alissa89@gmail.com
About this study
Official title: 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
- Conditions
- Thyroid Surgery
- Being tested
- Intermediate cervical block
- Keywords
- thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate cervical blockDrug
Local anesthesia performed in addition to the general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 %) Receives: Drug: Intermediate cervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on recurrent laryngeal nerve monitoring
Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring
Measured: Before surgical dissection
Secondary outcomes (5)
Postoperative recovery
Ability to return to work assessed by a composite questionnaire (QOR15 / FRI / patient's personal opinion)
Measured: 7 days post surgery
Postoperative pain
Numerical rating pain scale (0 = no pain to 10 = worst pain)
Measured: First 24 hours post surgery
Early postoperative complications
Number of patients with hypocalcemia, hematoma, nausea, vomiting
Measured: First 24 hours post surgery
Postoperative dysphonia
Number of patients with post-operative dysphonia
Measured: 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
Measured: 1 to 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start28 Nov 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Francois Baclesse
- Responsible party
- Sponsor
- Investigators
- Emmanuel Babin, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585126
- Sponsor's protocol ID
- 19-105
- Acronym
- THYRODOUL2
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04585126
- Acronym / sponsor ID
- THYRODOUL2 / 19-105
- Conditions
- Thyroid Surgery
- Keywords
- thyroid surgery, cervical nerve block, recurrent laryngeal nerve monitoring, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Francois Baclesse
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blinded, non inferiority study comparing general anesthesia combined with cervical nerve block vs general anesthesia alone in thyroid surgery
| Arm | Type | Receives |
|---|---|---|
| General anesthesia without intermediate cervical block | No intervention | –General anesthesia performed by the anesthesiologist |
| General anesthesia with intermediate cervical block | Active comparator | Drug: Intermediate cervical blockGeneral 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 %) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermediate cervical blockLocal anesthesia performed in addition to the general anesthesia | Drug | General anesthesia with intermediate cervical block |
Primary outcome
Effect on recurrent laryngeal nerve monitoring
Time frame: Before surgical dissection
Percentage of bilateral and unilateral non-response to recurrent laryngeal nerve monitoring
5 secondary outcomes
Postoperative recovery
Time frame: 7 days post surgery
Postoperative pain
Time frame: First 24 hours post surgery
Early postoperative complications
Time frame: First 24 hours post surgery
Postoperative dysphonia
Time frame: During the first 24 hours and 7 days post surgery
Late postoperative complications
Time frame: 1 to 3 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Babin principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermediate cervical block in people with Thyroid Surgery, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gulbhar AL ISSA (+33678548573, g.alissa89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on recurrent laryngeal nerve monitoring (time frame: Before surgical dissection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.