Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation

Superior Laryngeal Nerve Block Clinical Trial

Official title:

Ultrasound-guided Thyroid Cartilage Plane Block for Patients With Awake Tracheal Intubation: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065475
• Other study ID #: KY20230829-10
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Tao Shan
• Phone: 18852095135
• Email: 858727933[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the clinical effectiveness and safety of superior laryngeal nerve block through surface injection of local anesthetic solution on the thyroid cartilage in patients undergoing general anesthesia with endotracheal intubation. The main questions it aims to answer are the effectiveness of ultrasound-guided Thyroid Cartilage Plane Block for superior laryngeal nerve blockadethe and the safety and ease of performance.

All patients are divided into the Thyroid Cartilage Plane Block Group (T Group) and the Control Group (C Group). Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the procedure. In the experimental T Group, ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. Local anesthetic is injected on the surface of the thyroid cartilage plate.

Compare the following parameters between the two groups: duration of the blocking procedure, Ramsay Sedation Score, patient coughing upon contact of the fiberoptic bronchoscope with the vocal cords before intubation, comfort score immediately after intubation, and tracheal tube tolerance after successful intubation.

Description:

Select 60 patients undergoing elective awake tracheal intubation surgery. Instruct patients to fast （no food or drink） for 8 hours before the procedure. Upon admission to the operating room, monitor patients' ECG （electrocardiogram）, BP （blood pressure）, and SpO2 （pulse oxygen saturation）. Establish intravenous access in the upper extremities and administer normal saline solution. Administer a loading dose of dexmedetomidine at 0.5 μg/kg over 5 minutes, followed by an infusion at a rate of 0.3-0.6 μg/（kg·h） and intravenous injection of fentanyl at 0.1 μg/kg. Perform radial artery puncture and catheter placement for invasive arterial pressure monitoring. Use a computer-generated random number table to allocate patients into two groups in a 1:1 ratio. To ensure objectivity, a nurse not involved in the study prepares sealed opaque envelopes containing the group assignments. All patients are divided into the Thyroid Cartilage Plane Block Group （T Group） and the Control Group （C Group）. Patients in the C Group receive airway surface anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the procedure. In the experimental T Group, ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. Local anesthetic is injected on the surface of the thyroid cartilage plate. The blocking procedure is as follows: Use a Sonosite high-frequency linear array transducer (5-13 MHz, Sonosite, USA). Place the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage plate under ultrasound. Employ ultrasound-guided in-plane or out-of-plane techniques to display the needle insertion path and tip. Once the needle tip contacts the upper half of the thyroid cartilage plate, inject 3ml of 2% lidocaine on the surface of the thyroid cartilage plate （the dosage is consistent with the commonly used local anesthetic volume for classic superior laryngeal nerve block methods in clinical practice）. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, select an appropriate-sized tracheal tube and perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients scheduled for awake tracheal intubation surgery under general anesthesia.

2. Patients with difficult airways (e.g., limited cervical spine mobility, full stomach, partial airway obstruction, craniofacial deformities or trauma, micrognathia, mouth opening <3cm, Mallampati III or IV classification) posing challenges for mask ventilation or intubation.

3. Age between 18 and 65 years.

4. Gender is not restricted.

5. ASA classification of I or II.

Exclusion Criteria:

1. Cardiovascular dysfunction or arterial aneurysms.

2. Mental or neurological disorders or concomitant arterial aneurysms.

3. Infection at the puncture site.

4. Allergy to local anesthetics.

5. Continuous use of antiplatelet or anticoagulant medications preoperatively.

6. Hoarseness or coughing while drinking water.

7. Bronchial asthma.

8. Participation in other clinical trials within the previous 3 months before enrollment 9.r current participation in other clinical trials.

Related Conditions & MeSH terms

• Superior Laryngeal Nerve Block
• Thyroid Diseases

Intervention

Behavioral:
• Ultrasound-guided bilateral Thyroid Cartilage Plane Block
Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Place the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage plate under ultrasound. Employ ultrasound-guided in-plane or out-of-plane techniques to display the needle insertion path and tip. Once the needle tip contacts the upper half of the thyroid cartilage plate, inject 3ml of 2% lidocaine on the surface of the thyroid cartilage plate.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Canty DJ, Poon L. Superior laryngeal nerve block: an anatomical study comparing two techniques. J Clin Anesth. 2014 Nov;26(7):517-22. doi: 10.1016/j.jclinane.2014.03.005. Epub 2014 Oct 16. — View Citation

Fowler JG, VanEenenaam DP Jr, Johnson KN, Courtemanche CD, Strathman AJ, Reynolds JE. Single midline injection for bilateral superior laryngeal nerve block. J Clin Anesth. 2020 Nov;66:109922. doi: 10.1016/j.jclinane.2020.109922. Epub 2020 Jun 6. No abstract available. Erratum In: J Clin Anesth. 2023 Jul 29;:111195. — View Citation

Wiles JR, Kelly J, Mostafa SM. Hypotension and bradycardia following superior laryngeal nerve block. Br J Anaesth. 1989 Jul;63(1):125-7. doi: 10.1093/bja/63.1.125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of airway anesthesia	TThe primary outcome in this trial was quality of airway anesthesia assessed on a 5-point scale,Quality of airway anesthesia was graded as: 0=no coughing or gagging in response to intubation, 1=mild coughing and/or gagging that did not hinder intubation, 2=moderate coughing and/or gagging that interfered minimally with intubation, 3=severe coughing and/or gagging that made intubation difficult and 4=very severe coughing and/or gagging that required additional local anesthetic and/or change in technique.The lower grade means a better quality of airway anesthesia.	Upon intubation
Secondary	Mean Arterial Pressure (MAP)	Stable blood pressure indicates a good neural blockade effect.	T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Secondary	Heart Rate (HR)	The smaller the heart rate fluctuations, the better the neural blockade effect.	T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Secondary	Ramsay Sedation Score	The Ramsay Sedation Score is as follows: 6 points for unarousable, 5 points for slow response to stimulus, 4 points for asleep but easily aroused, 3 points for quiet and cooperative with orientation, 2 points for asleep, anxious, restless, and 1 point for asleep, agitated, and restless. Satisfactory sedation falls within 2-4 points, while oversedation is indicated by 5-6 points.	T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation
Secondary	The number of patients with lowered pitch	A lowered pitch indicates a good neural blockade effect.	Before intubation
Secondary	The time of the block procedure	The neural blockade procedure time reflects the ease of the operation, with a shorter time indicating a simpler neural blockade procedure.	From ultrasound probe positioning the target to completion of drug administration
Secondary	Record coughing in patients when the fiberoptic bronchoscope touches the glottis	The patient's coughing upon contact of the fiberoptic bronchoscope with the vocal cords before intubation reflects the effectiveness of neural blockade. A lower degree of coughing indicates a better neural blockade effect. 1 point for no response, 2 points for mild cough, 3 points for severe cough.	Before intubation
Secondary	The tolerance of the tube	The tolerance of the tube reflects the patient's tolerance to awake tracheal intubation. A higher level of tolerance indicates a better neural blockade effect. 3 points for severe resistance requiring immediate general anesthesia, 2 points for restlessness and mild resistance, 1 point for cooperation.	After successful intubation
Secondary	Adverse reactions such as coughing and nausea/ vomiting..	The lower the incidence of coughing, nausea, and vomiting, the better the neural blockade effect.	During intubation
Secondary	Occurrences of sore throat and lowered pitch	Pharyngeal pain and decreased vocal tone are used to assess postoperative complications of neural blockade.	Post-extubation,24 hours after surgery