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

Phase 2

Completed

• Conditions: Lung Cancer; Interstitial Lung Disease; Sarcoidosis; Tuberculosis
• Interventions: Drug: 1% lignocaine; Drug: 2% lignocaine

• Registration Number: NCT01955824
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Study Start: 2014-05
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-26
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% lignocaine	1% lignocaine	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.
2% lignocaine	2% lignocaine	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bronchoscopy suite, PGIMER; 🇮🇳 Chandigarh, India