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

NCT06483893 | Recruiting

• 1 other identifier: FMBSUREC/04062024/Fakhry
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction

Keywords

Thyroid Cartilage; Awake Fiberoptic Intubation; Cervical Spine; Superior Laryngeal Nerve

Outcome Measures

Primary Outcomes (1)

• the time taken to perform block

  from the start of ultrasound probe positioning to completion of drug administration

  During surgery, upon performing block

Secondary Outcomes (2)

• quality of airway anesthesia a

  During surgery, upon 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 ]

Study Arms (2)

thyroid cartilage plane block group (TCPB Group)

ACTIVE COMPARATOR

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)

traditional superior laryngeal nerve block group (Traditional SLNB Group)

ACTIVE COMPARATOR

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)

Interventions

US-guided thyroid cartilage plane block (group TCPB) 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.

thyroid cartilage plane block group (TCPB Group)

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

traditional superior laryngeal nerve block group (Traditional SLNB Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, 62814, Egypt

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dina M Fakhry

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Fakhry, MD

CONTACT

+201289998680; dina_fakhry_91@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

EG (1)