Ultrasound-guided Thyroid Cartilage Plane Block for Awake Intubation

NCT06065475 | Completed DMC

• 1 other identifier: KY20230829-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 as an anatomical landmark. Local anesthetic is injected on the surface of the thyroid cartilage. 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.

Conditions

Superior Laryngeal Nerve Block

Keywords

Thyroid Cartilage; Superior Laryngeal Nerve; Difficult airway; ultrasound; Awake tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean Arterial Pressure （MAP）

  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

• Heart Rate （HR）

  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

• Ramsay Sedation Score

  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

• The number of patients with lowered pitch

  Before intubation

• The time of the block procedure

  From ultrasound probe positioning the target to completion of drug administration

Study Arms (2)

Thyroid Cartilage Plane Block Group (T Group)

EXPERIMENTAL

All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, perform fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.

Behavioral: Ultrasound-guided bilateral Thyroid Cartilage Plane Block

the Control Group （C Group）

NO INTERVENTION

Patients in the C Group received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Patients in the C Group receive airway topical anesthesia using the fiberoptic bronchoscope-guided local anesthetic spray method throughout the vocal cord and tracheal with 5 ml 2% lidocaine respectively.

Interventions

Ultrasound-guided bilateral Thyroid Cartilage Plane Block BEHAVIORAL

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 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, injecting 2.5ml of 2% lidocaine on the surface of the thyroid cartilage each side.

Thyroid Cartilage Plane Block Group (T Group)

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for awake tracheal intubation surgery under general anesthesia.
• 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.
• Age between 18 and 65 years.
• Gender is not restricted.
• ASA classification of I or II.

You may not qualify if:

• Cardiovascular dysfunction or arterial aneurysms.
• Mental or neurological disorders or concomitant arterial aneurysms.
• Infection at the puncture site.
• Allergy to local anesthetics.
• Continuous use of antiplatelet or anticoagulant medications preoperatively.
• Hoarseness or coughing while drinking water.
• Bronchial asthma.
• Participation in other clinical trials within the previous 3 months before enrollment 9.r current participation in other clinical trials.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Nanjing, 210006, China

Location

Related Publications (3)

• 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.

  PMID: 2765339 BACKGROUND

• 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.

  PMID: 25439414 BACKGROUND

• 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.

  PMID: 32516680 BACKGROUND

Study Officials

• Tao Shan

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 4, 2023
• Study Start: October 15, 2023
• Primary Completion: December 27, 2024
• Study Completion: December 28, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)