Thyroid Cartilage Plane Versus Superior Laryngeal Nerve Space for Ultrasound-guided Superior Laryngeal Nerve Block in Awake Tracheal Intubation: a Randomised Non-inferiority Clinical Trial
Sponsor study identifier
interventional
94
1 country
2
Study Start
February 11, 2026
Actual (reported)Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. The investigators 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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2026
Actual (reported)February 9, 2026
Actual (reported)February 11, 2026
Actual (reported)September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Nanjing First Hospital
Nanjing, 210006, China
Tao Shan
Nanjing First Hospital, Nanjing Medical University
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
February 11, 2026
Actual (reported)Primary Completion
September 1, 2027
EstimatedUse 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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 28, 2026
Record last verified: 2026-07
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