Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation

NCT07397234 | Not Yet Recruiting DMC

• 1 other identifier: KY20260108-04
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Patients were randomized into the thyroid cartilage plane block group (T group) or the superior laryngeal nerve space block group (C group). In Group T, bilateral thyroid cartilage plane block was performed under ultrasound with thyroid cartilage as the landmark, and local anesthetic was injected on the surface of the thyroid cartilage. In Group C, local anesthetic was injected into the space between the thyrohyoid membrane and muscle groups above. We aim to evaluate whether the thyroid cartilage plane approach is not inferior to the superior laryngeal nerve space approach for ultrasound-guided superior laryngeal nerve block in awake tracheal intubation

Conditions

Superior Laryngeal Nerve Block

Keywords

Thyroid Cartilage plane; Superior laryngeal nerve space; Difficult airway; Superior Laryngeal Nerve; Awake tracheal intubation; Nerve block

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with acceptable intubation conditions (AIC)

  The evaluation of the intubation condition was based on the Cormack-Lehane classification, vocal cord movement, 5-point reaction scale, and severity of coughing. Clinically, AIC was defined when each part was scaled to Grade 1 or Grade 2. The proportion of AIC = number of participants with AIC/number of participants who received ATI in each group.

  Upon intubation

Secondary Outcomes (12)

• Quality of airway anesthesia

  Upon intubation

• Mean Arterial Pressure

  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

  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

Study Arms (2)

Superior Laryngeal Nerve Space Block Group (C Group)

ACTIVE COMPARATOR

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. Under ultrasound guidance, the needle was advanced step by step into the potential space between the relevant muscle groups and the thyrohyoid membrane. When the needle tip contacted the surface of the thyrohyoid membrane and slightly penetrated the submembranous tissue, negative aspiration was confirmed, and 2.5 mL of 2% lidocaine was injected into the space on each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation.

Procedure: Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block

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 as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 2% lidocaine 5ml. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation.

Procedure: Ultrasound-guided bilateral Thyroid Cartilage Plane Block

Interventions

Ultrasound-guided bilateral Thyroid Cartilage Plane Block PROCEDURE

Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the thyroid cartilage under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. Once the needle tip contacts the cranial half of the thyroid cartilage, injecting 2.5ml of 2% lidocaine on the surface of the thyroid cartilage each side.

Thyroid Cartilage Plane Block Group (T Group)

Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block PROCEDURE

Use a SonoSite high-frequency linear array transducer (5-13 MHz, SonoSite, USA). Placing the transducer parallel to the spine on one side of the neck, ensuring clear visualization of the superior laryngeal nerve space under ultrasound. Using the out-of-plane technique to visualize the needle insertion path and tip. 2% lidocaine 2.5ml was injected into the space between the thyrohyoid membrane and muscle groups above.

Superior Laryngeal Nerve Space Block Group (C Group)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for awake tracheal intubation 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 85 years old.
• Gender is not restricted.
• ASA classification of I - III.

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, Jiangsu, 210006, China

Location

Study Officials

• Tao Shan

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Shan

CONTACT

+8618852095135; 858727933@qq.com

Ying Zhang

CONTACT

+8615380998716; 1070434273@qq.com

Study Design

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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)