Patient SatisfactionNCT06483893
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
A study testing US-guided thyroid cartilage plane block (group TCPB) and US-guided traditional superior laryngeal nerve block (group traditional SLNB) in people with Patient Satisfaction, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- US-guided thyroid cartilage plane block (group TCPB) and US-guided traditional superior laryngeal nerve block (group traditional SLNB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients aged between 18-65 years
- either gender
- ASA I-II
- limited neck mobility
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University hospital
Banī Suwayf, Beni Suweif Governorate, 62814
Dina M Fakhry, MD, +201289998680, dina_fakhry_91@yahoo.com
Dina M Fakhry, +201289998680, dina_fakhry_91@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Satisfaction
- Being tested
- US-guided thyroid cartilage plane block (group TCPB), US-guided traditional superior laryngeal nerve block (group traditional SLNB)
- Keywords
- Thyroid Cartilage, Awake Fiberoptic Intubation, Cervical Spine, Superior Laryngeal Nerve
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided thyroid cartilage plane block (group TCPB)Procedure or surgery
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.
US-guided traditional superior laryngeal nerve block (group traditional SLNB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: US-guided traditional superior laryngeal nerve block (group traditional SLNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time taken to perform block
from the start of ultrasound probe positioning to completion of drug administration
Measured: During surgery, upon performing block
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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 ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
- Investigators
- Dina M Fakhry, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483893
- Sponsor's protocol ID
- FMBSUREC/04062024/Fakhry
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06483893
- Acronym / sponsor ID
- FMBSUREC/04062024/Fakhry
- Conditions
- Patient Satisfaction
- Keywords
- Thyroid Cartilage, Awake Fiberoptic Intubation, Cervical Spine, Superior Laryngeal Nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thyroid cartilage plane block group (TCPB Group) | Active comparator | 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. |
| traditional superior laryngeal nerve block group (Traditional SLNB Group) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged between 18-65 years
- either gender
- ASA I-II
- limited neck mobility
Key exclusion criteria (7 listed)
- patients who refuse to give consent
- non-cooperative patients
- have asthma or ischemic heart disease
- preoperative hoarseness, sore throat
- mental or neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | thyroid cartilage plane block group (TCPB Group) |
| 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. | Procedure or surgery | traditional superior laryngeal nerve block group (Traditional SLNB Group) |
Primary outcome
the time taken to perform block
Time frame: During surgery, upon performing block
from the start of ultrasound probe positioning to completion of drug administration
2 secondary outcomes
quality of airway anesthesia a
Time frame: During surgery, upon intubation
Ramsay Sedation Score
Time frame: 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 ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina M Fakhry principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided thyroid cartilage plane block (group TCPB) and US-guided traditional superior laryngeal nerve block (group traditional SLNB) in people with Patient Satisfaction, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Fakhry, MD (+201289998680, dina_fakhry_91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time taken to perform block (time frame: During surgery, upon performing block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.