A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy

Study Overview
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Brief Summary
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Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.

Official Title
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A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY

Conditions
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Lung Cancer, Tuberculosis, Sarcoidosis, Interstitial Lung Disease

Intervention / Treatment
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* Drug: 1% lignocaine
* Drug: 2% lignocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients undergoing flexible bronchoscopy Hemodynamic stability Exclusion Criteria: Patients receiving sedatives during the course of their treatment Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation Patients with known hypersensitivity to lignocaine Not willing to provide informed consent

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% lignocaine<br>Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (1%) 8ml will be administered as spray as you go technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. | Drug: 1% lignocaine<br> <br> |
| Active Comparator: 2% lignocaine<br>Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (2%) 8ml will be administered as spray as you go technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. | Drug: 2% lignocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough suppression (by Operator and Patient) | Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever) | 15 minutes | 
| Pain control | Pain will be assessed on Wong Baker Face rating scale | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoscopy, lignocaine, cough