A Randomized Trial of 4% Nebulized Lignocaine vs. 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy

Study Overview
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Brief Summary
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Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Detailed Description
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Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. The bronchoscope can be used to sample material not only from the visualized regions but also from the more distal pulmonary parenchyma. It is a safe outpatient exam that carries little risk. While performing the procedure most of the patients express some fear of pain, difficulty in breathing, nasopharyngeal irritation, and cough. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Administration of a topical anaesthetic drug to the upper airway, larynx, and tracheobronchial tree can reduce a cough and patient's discomfort. The most commonly used topical anaesthetic agent in bronchoscopy is lignocaine because of its quick onset and short duration of action with decreased toxicity as compared to other agents. There are several ways to achieve topical anaesthesia in flexible bronchoscopy including nebulization, direct spray, by tracheal injection, or via nasal, or spray as you go technique through the working channel of the bronchoscope. The use of topical anaesthesia, sedation, and analgesia during flexible bronchoscopy varies according to physicians, institutions and geographic locations in the world. Generally, moderate sedation is used in bronchoscopy in which patients can respond to verbal commands. Deep sedation is less commonly used in which patients cannot be easily aroused but respond to repeated or painful stimulation. Antoniades et al. demonstrated that topical lidocaine through the bronchoscope significantly decreased cough frequency and the total dose of sedation required during flexible bronchoscopy. In a randomized controlled trial of 54 patients, Keane et al. concluded that nebulized and sprayed lignocaine have similar efficacy as topical anaesthetics in fiberoptic bronchoscopy but patients preferred the nebulized route. Noitasaeng et.al. concluded in their study that spraying lidocaine took less time to start the procedure, with greater ease of instrumentation, less incidence of hypersecretion, less gag reflex, and smooth operation during the procedure but patients preferred nebulized lidocaine administration. At the investigators' center, it has been a routine practice to perform flexible bronchoscopy without sedation in patients who require only diagnostic flexible bronchoscopy and assessment of airway anatomy and other routine procedures such as endobronchial biopsy or transbronchial biopsy. Previously, the investigators had shown that 1% lignocaine given by spray-as-you-go method was similar in efficacy to 2% lignocaine for topical anesthesia during routine flexible bronchoscopy. However, in this study both the groups received nebulized lignocaine and lignocaine spray prior to flexible bronchoscopy in addition to lignocaine solution ad lib. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Official Title
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A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy

Conditions
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Patients With Indication for Flexible Bronchoscopy

Intervention / Treatment
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* Drug: Nebulized Lignocaine
* Drug: Lignocaine spray
* Drug: Combined spray and nebulization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Willing for flexible bronchoscopy procedure a Exclusion Criteria: Requirement of intravenous sedation to undergo any procedure including EBUS-TBNA, conventional TBNA, radial EBUS procedure and interventional pulmonary procedures Sensitivity to lignocaine Hemodynamically unstable patients (SBP < 90 mm Hg) Baseline hypoxemia (SpO2 <92% on room air) Pregnancy Comorbid illness such as heart failure, CKD, chronic liver disease and others Failure to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized lignocaine<br>2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy | Drug: Nebulized Lignocaine<br>* 2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy<br>|
| Experimental: Lignocaine spray<br>10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy | Drug: Lignocaine spray<br>* 10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy<br>|
| Active Comparator: Combined spray and nebulization<br>Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy | Drug: Combined spray and nebulization<br>* Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated intensity of cough on a visual analog scale (VAS) | The cough VAS is a 100-mm scale anchored by no cough on one end and worst cough on the other; the patient will indicate the severity of a cough by marking a line. | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment by the patient using the faces pain rating scale | The Wong-Baker Faces Pain Scale combines the pictures and numbers to allow pain to be rated by the user. The faces range from smiling face to a sad, crying face. A numerical rating is assigned to each face, of which there is 6 total, where zero rating means no pain with smiling face and 10 mean worst pain with crying face | One hour | 
| Patient-rated VAS of overall satisfaction of the procedure | VAS on a 100-mm scale | One hour | 
| Operator-rated intensity of cough on a VAS | VAS on a 100-mm scale | Immediately following the procedure | 
| Total lignocaine dose | Total dose of lignocaine in milligrams | Immediately following the procedure | 
| Changes in respiratory rate following the procedure | Respiratory rate at baseline and 5 minutes after the procedure | Baseline and 5 minutes after the procedure | 
| Changes in heart rate following the procedure | Heart rate at baseline, during and 5 minutes after the procedure | Baseline, during and 5 minutes after the procedure | 
| Changes in blood pressure following the procedure | Blood pressure at baseline and 5 minutes after the procedure | Baseline and 5 minutes after the procedure | 
| Changes in oxygenation status following the procedure | Pulse oximetric saturation at baseline, during and 5 minutes after the procedure | Baseline, during and 5 minutes after the procedure | 
| Duration of procedure (in minutes) | The total duration of bronchoscopy procedure in minutes | Immediately following the completion of flexible bronchoscopy | 
| Willingness of the patient to undergo the procedure yet again, if required | Patient will indicate the willingness to undergo the procedure again, if required by a simple yes or no | One hour | 
| Adverse reactions related to lignocaine | Arrhythmia, involuntary movements, convulsions, anaphylaxis and bronchospasm | One hour |