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

NCT ID: NCT06483893

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

US-guided thyroid cartilage plane block (group TCPB)

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

US-guided traditional superior laryngeal nerve block (group traditional SLNB)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina M Fakhry

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

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Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dina M Fakhry, MD

Role: CONTACT

+201289998680

Facility Contacts

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Dina M Fakhry, MD

Role: primary

+201289998680

Dina M Fakhry

Role: backup

+201289998680

Other Identifiers

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FMBSUREC/04062024/Fakhry

Identifier Type: -

Identifier Source: org_study_id

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