Trials / Not Yet Recruiting
Not Yet RecruitingNCT07397234
Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- Sponsor
- Nanjing First Hospital, Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Detailed description
After entering the operation room, ECG, SPO2, and invasive blood pressure were monitored. Sedation was facilitated. The proper anaesthesia depth was maintained at 60-80 using the bispectral index. Additionally, 0.5 mg of Penehyclidine Hydrochloride was injected intravenously once the venous access was established. 100% oxygen 4 L min-1 was administered with a nasal cannula throughout the procedure. All patients received topical pharyngeal anesthesia using lidocaine spray. We used a 5-12 MHz linear probeto perform bilateral block. The probe was placed parasagittally to locate the thyroid cartilage and superior laryngeal nerve space. After identification of related structure, we advanced a 22-gauge needle medial to the transducer at the upper half of the thyroid cartilage laminae until it touched the laminae or superior laryngeal nerve space using the out-of-plane technique. The correct location of the needle tip in the fascial deep to the muscle groups was confirmed by injecting 0.5-1 ml saline. A total of 2% lidocaine 2.5 ml was administered after negative aspiration bilaterally. "Spray-as-you-go" technique guided by a fiberoptic bronchoscope was performed to the tracheal with 5 ml of 2% lidocaine. After airway anesthesia, intubation completed. The primary outcome was the proportion of acceptable intubation conditions (AIC). Secondary outcomes were the performance time, Ramsay sedation score, the patient's cough condition, comfort score, and tracheal tube tolerance score and other perioperative complications including airway hemorrhage and superior laryngeal nerve damage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ultrasound-guided bilateral Thyroid Cartilage Plane Block | 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. |
| PROCEDURE | Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block | 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. |
Timeline
- Start date
- 2026-03-02
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2026-02-09
- Last updated
- 2026-02-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07397234. Inclusion in this directory is not an endorsement.