Ultrasound-Guided Thyroid Cartilage Plane Block vs Ultrasound-Guided Traditional Superior Laryngeal Nerve Block for Awake Fiberoptic Intubation in Patients With Limited Neck Mobility Undergoing Cervical Spine Fixation

Comparison of Ultrasound-Guided Thyroid Cartilage Plane Block and Ultrasound-Guided Traditional Superior Laryngeal Nerve Block for Awake Fiberoptic Intubation in Patients With Limited Neck Mobility Undergoing Cervical Spine Fixation

The aim of the work to compare between the effectiveness and safety of ultrasound-guided superior laryngeal nerve block through surface injection of local anesthetic solution on the thyroid cartilage and ultrasound-guided traditional superior laryngeal nerve block on quality of airway anesthesia for awake fiberoptic intubation in patients with limited neck mobility undergoing cervical spine fixation.

Study Overview

• Status: Recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Procedure: US-guided thyroid cartilage plane block (group TCPB); Procedure: US-guided traditional superior laryngeal nerve block (group traditional SLNB)

Detailed Description

The difficult airway is a challenge for the anesthesiologist. When a patient presents with anticipated difficult airway, the strategies can be varied, depending on the clinical context, the available resources, and the level of training of human resources. However, most clinical practice guidelines agree that difficult airway management shall be approached with the patient awake. Intubating the patient awake improves the perioperative safety, since it allows for spontaneous breathing, maintaining the patency of the airway, and cooperation with the operator.

Awake fibreoptic intubation (AFOI) is the gold standard in the management of the difficult airway.

Several ways to administer local anaesthetic to the upper airway to aid AFOI have been described including nebulisation, spray-as-you-go techniques and airway nerve blocks, each with its own potential advantages and disadvantages.

The objective of the ideal technique is the use of the lowest possible dose of the local anesthetic agent, to achieve a successful block that facilitates the intubation conditions, and increases the safety and tolerability of the patient.

Airway topicalization is commonly used to facilitate awake tracheal intubation and can be implemented in various ways. There are reservations about performing topical anesthesia of the airway because of some unsolved drawbacks, including poor airway anesthesia quality due to unreliable effects and the increased risk of exceeding the maximum dose of local anesthesia, leading to local anesthetic systemic toxicity (LAST).

Airway nerve blocks provide better anesthesia quality for awake tracheal intubation and lower overall complications than topical anesthesia.

Ultrasound-guided superior laryngeal nerve block is a viable alternative for topical anesthesia during awake tracheal intubation. However, direct recognition of the superior laryngeal nerve under ultrasonography can be challenging due to its small dimensions and large probe size. Several methods have been reported to block the superior laryngeal nerve, utilizing the thyroid hyoid membrane and superior laryngeal artery as anchors to locate the superior laryngeal nerve.

Thyroid cartilage plane block is a new approach for local anesthetic injection targeting an interfascial plane between the thyroid cartilage laminae and the muscle groups above. This approach, distant from any nerves or vascular structures, may offer enhanced safety compared to the superior laryngeal nerve space block.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina M Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com

Study Locations

• Egypt
  • Beni Suef
    • Banī Suwayf, Beni Suef, Egypt, 62814
      • Recruiting
      • Beni-suef university Hospital
      • Contact: Dina M Fakhry, MD; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com
      • Contact: Dina M Fakhry; Phone Number: +201289998680; Email: dina_fakhry_91@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients aged between 18-65 years
• either gender
• ASA I-II
• limited neck mobility

Exclusion Criteria:

• patients who refuse to give consent
• non-cooperative patients
• have asthma or ischemic heart disease
• preoperative hoarseness, sore throat
• mental or neurological disorders
• contraindications for regional block (coagulopathy , infection at the needle insertion site and allergy to local anesthetics)
• body mass index (BMI) >26 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: thyroid cartilage plane block group (TCPB Group); Participants in the (group TCPB) will receive US-guided thyroid cartilage plane block. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 3ml of 2% lidocaine is injected on the surface of the thyroid cartilage plate. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.	Procedure: US-guided thyroid cartilage plane block (group TCPB); Participants in the (group TCPB) will receive US-guided thyroid cartilage plane block. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage plate as an anatomical landmark. 3ml of 2% lidocaine is injected on the surface of the thyroid cartilage plate. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.
Active Comparator: traditional superior laryngeal nerve block group (Traditional SLNB Group); Participants in the (group traditional SLNB) will receive US-guided traditional superior laryngeal nerve block. Traditional Superior Laryngeal Nerve Block is performed using the thyrohyoid muscle and thyrohyoid membrane as an anatomical landmark. The thyroid cartilage and the greater horn of hyoid bone are hyperechoic signals on sonography. 3ml of 2% lidocaine is injected above the thyrohyoid membrane next to the superior laryngeal artery between two hyperechoic structures. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.	Procedure: US-guided traditional superior laryngeal nerve block (group traditional SLNB); Participants in the (group traditional SLNB) will receive US-guided traditional superior laryngeal nerve block. Traditional Superior Laryngeal Nerve Block is performed using the thyrohyoid muscle and thyrohyoid membrane as an anatomical landmark. The thyroid cartilage and the greater horn of hyoid bone are hyperechoic signals on sonography. 3ml of 2% lidocaine is injected above the thyrohyoid membrane next to the superior laryngeal artery between two hyperechoic structures. Subsequently, perform fiberoptic bronchoscope-guided oropharyngeal, subglottic, and tracheal surface anesthesia. After completing surface anesthesia, perform fiberoptic bronchoscope-guided tracheal intubation, securing it properly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time taken to perform block	from the start of ultrasound probe positioning to completion of drug administration	During surgery, upon performing block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of airway anesthesia a	Assessment of quality of airway anesthesia was done on a 5-point scale as described by Reasoner et al.[13] 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, 4 = very severe coughing and/or gagging that required additional local anesthetic (LA) and/or change in technique to achieve successful intubation.	During surgery, upon intubation
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 ]

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Dina M Fakhry, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cervical Spine; Thyroid Cartilage; Superior Laryngeal Nerve; Awake Fiberoptic Intubation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: FMBSUREC/04062024/Fakhry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No