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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sarcoidosis; Tuberculosis; Lung Cancer; Interstitial Lung Disease

Treatments: Drug: 2% lignocaine; Drug: 1% lignocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01955824

Bron/Lig/Tr-1

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

1% lignocaine

Experimental group

Description:

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.

Treatment:

Drug: 1% lignocaine

2% lignocaine

Active Comparator group

Description:

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.

Treatment:

Drug: 2% lignocaine