Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic IntubationNCT05550051
Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns.
A study testing Awake nasal fiberoptic intubation in people with Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic Intubation, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic Intubation
- What is being tested?
- Awake nasal fiberoptic intubation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Sep 2022to 5 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients above 18 years with ASA classification II, III, and no known hypersensitivity for local anesthetics
Who cannot join
- Patient refusal
- Patients under 18 years
- Patients suffering from coagulopathies or bleeding tendencies
- Patients with ASA 4 classification
- Non cooperative patients
- Patients undergoing extensive facial reconstruction
- Patients with known hypersensitivity to lignocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns. A Randomized Controlled Study.
This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block.
Read the detailed description
Adequate preparation for Awake Fiberoptic Intubation (AFOI) is an art of anesthesia which includes, many methods such as blocking nerves supplying the upper airway including the superior laryngeal, recurrent laryngeal, and glossopharyngeal nerves. Topical anesthesia via a special cannula as you proceed, and lignocaine nebulization. Succeeding in blocking the airway adequately is the first step towards a successful AFOI.
Although many studies have been done to compare the topical anesthesia technique versus the airway block techniques but theses studies have ignored the fact that in many cases of difficult airway indicated for AFOI there is limited or even absent neck mobility, and mouth opening both which are mandatory to perform an adequate airway neural block.
After anesthetizing the airway in both groups either by nebulization or airway block, an anesthesiologist who will be blinded to the study groups will perform the (AFOI) by using an endotracheal tube size 7.5 mm internal diameter endotracheal tube for males and 7 mm for female patients.
Vital signs such as HR, BP, and oxygen saturation (SpO2) will be recorded recorded immediately after intubation and 5 min postintubation and at every 10 minutes during surgery.
The patient response, and satisfaction with the technique will be recorded by using the revised non verbal pain scale (NVPS-R).
The (NVPS-R) is a multidimensional instrument formed of three behavioral (face, activity/movement, and guarding) responses, physiological indicators, and RR.
Patients will be randomly divided into two groups using a computer generated random number chart. Group (AB) will undergo AFOI after performing an airway block prior to the procedure while group (LN) will undergo AFOI after lignocaine nebulization 30 minutes prior to the procedure.
Group (AB) will have an upper airway block by using about lignocaine 2%; the following nerves will be blocked.
Bilateral superior laryngeal nerve block and will be performed after placing the patients in a supine position, with slight neck extension to identify the hyoid bone. Sterilization of the site of injection by 10% povidone iodine will be performed. After identification of the hyoid bone the bone will be move towards the site of injection, where a sterile 25G needle will be inserted laterally aiming at the greater cornu, and after hitting the bone with the needle, it will slide under the bone inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve.
Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by placing the patient supine, with the neck extended to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A 22G needle will be inserted perpendicular to the cricothyroid membrane to penetrate it while aspirating and once air bubbles appear this will mean that we are intra tracheal, then injection of 5ml of 4% lignocaine will result in coughing and dispersing of the LA, blocking the nerve.
While patients in group (LN) will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.
- Being tested
- Awake nasal fiberoptic intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake nasal fiberoptic intubationProcedure or surgery
Lignocaine nebulization for upper airway block during awake nasal fiberoptic intubation
| Study group | Role | What they receive |
|---|---|---|
| lignocaine nebulization before awake nasal fiberoptic intubation | Active comparator | Patients will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting. Receives: Procedure: Awake nasal fiberoptic intubation |
| Upper airway block before awake nasal fiberoptic intubation | Active comparator | Upper airway block by using about lignocaine 2%, the block will be performed by:
1. Bilateral superior laryngeal nerve block and will be performed by slight neck extension to identify the hyoid bone. Insert the needle laterally aiming at the greater cornu, and after hitting the bone, it will slide inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve.
2. Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by extending the neck to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A needle will be inserted in the cricothyroid membrane while aspirating and once air bubbles appears, 5ml of 4% lignocaine will be injected resulting in cough and dispersing of the LA, blocking the nerve. Receives: Procedure: Awake nasal fiberoptic intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort during performing awake nasal fiberoptic intubation
Will be measured by the revised non verbal pain sale
Measured: 5 minutes
Time to performing awake nasal fiberoptic intubation
Will be measured by calculating the time to awake nasal fiberoptic intubation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start23 Sep 2022
- Primary completion2 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic IntubationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Refaat, Ain Shams University
- Investigators
- Sameh Refaat, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550051
- Sponsor's protocol ID
- R121/2022
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05550051
- Acronym / sponsor ID
- R121/2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 22 Sep 2022 (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.
This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block.
Detailed description
Adequate preparation for Awake Fiberoptic Intubation (AFOI) is an art of anesthesia which includes, many methods such as blocking nerves supplying the upper airway including the superior laryngeal, recurrent laryngeal, and glossopharyngeal nerves. Topical anesthesia via a special cannula as you proceed, and lignocaine nebulization. Succeeding in blocking the airway adequately is the first step towards a successful AFOI.
Although many studies have been done to compare the topical anesthesia technique versus the airway block techniques but theses studies have ignored the fact that in many cases of difficult airway indicated for AFOI there is limited or even absent neck mobility, and mouth opening both which are mandatory to perform an adequate airway neural block.
After anesthetizing the airway in both groups either by nebulization or airway block, an anesthesiologist who will be blinded to the study groups will perform the (AFOI) by using an endotracheal tube size 7.5 mm internal diameter endotracheal tube for males and 7 mm for female patients.
Vital signs such as HR, BP, and oxygen saturation (SpO2) will be recorded recorded immediately after intubation and 5 min postintubation and at every 10 minutes during surgery.
The patient response, and satisfaction with the technique will be recorded by using the revised non verbal pain scale (NVPS-R).
The (NVPS-R) is a multidimensional instrument formed of three behavioral (face, activity/movement, and guarding) responses, physiological indicators, and RR.
Patients will be randomly divided into two groups using a computer generated random number chart. Group (AB) will undergo AFOI after performing an airway block prior to the procedure while group (LN) will undergo AFOI after lignocaine nebulization 30 minutes prior to the procedure.
Group (AB) will have an upper airway block by using about lignocaine 2%; the following nerves will be blocked.
Bilateral superior laryngeal nerve block and will be performed after placing the patients in a supine position, with slight neck extension to identify the hyoid bone. Sterilization of the site of injection by 10% povidone iodine will be performed. After identification of the hyoid bone the bone will be move towards the site of injection, where a sterile 25G needle will be inserted laterally aiming at the greater cornu, and after hitting the bone with the needle, it will slide under the bone inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve.
Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by placing the patient supine, with the neck extended to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A 22G needle will be inserted perpendicular to the cricothyroid membrane to penetrate it while aspirating and once air bubbles appear this will mean that we are intra tracheal, then injection of 5ml of 4% lignocaine will result in coughing and dispersing of the LA, blocking the nerve.
While patients in group (LN) will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lignocaine nebulization before awake nasal fiberoptic intubation | Active comparator | Procedure: Awake nasal fiberoptic intubationPatients will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting. |
| Upper airway block before awake nasal fiberoptic intubation | Active comparator | Procedure: Awake nasal fiberoptic intubationUpper airway block by using about lignocaine 2%, the block will be performed by: 1. Bilateral superior laryngeal nerve block and will be performed by slight neck extension to identify the hyoid bone. Insert the needle laterally aiming at the greater cornu, and after hitting the bone, it will slide inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve. 2. Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by extending the neck to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A needle will be inserted in the cricothyroid membrane while aspirating and once air bubbles appears, 5ml of 4% lignocaine will be injected resulting in cough and dispersing of the LA, blocking the nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above 18 years with ASA classification II, III, and no known hypersensitivity for local anesthetics
Key exclusion criteria (7 listed)
- Patient refusal
- Patients under 18 years
- Patients suffering from coagulopathies or bleeding tendencies
- Patients with ASA 4 classification
- Non cooperative patients
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 |
|---|---|---|
| Awake nasal fiberoptic intubationLignocaine nebulization for upper airway block during awake nasal fiberoptic intubation | Procedure or surgery | Upper airway block before awake nasal fiberoptic intubation, lignocaine nebulization before awake nasal fiberoptic intubation |
Primary outcome
Patient comfort during performing awake nasal fiberoptic intubation
Time frame: 5 minutes
Will be measured by the revised non verbal pain sale
Time to performing awake nasal fiberoptic intubation
Time frame: 5 minutes
Will be measured by calculating the time to awake nasal fiberoptic intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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.
Sameh Refaat, MD principal investigator
Ain Shams 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 Awake nasal fiberoptic intubation in people with Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic Intubation, run by Ain Shams 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 1 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: finished, as of the sponsor's last update on 17 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort during performing awake nasal fiberoptic intubation (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 17 Feb 2023.