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NCT Number: NCT01955824

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

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.

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Key information

Conditions

Lung Cancer Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Cough Gram-Positive Bacterial Infections Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Infections Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Mycobacterium Infections Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoidosis Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms Tuberculosis

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% lignocaine

Drug

2% lignocaine

Drug

Primary outcomes

  1. Cough suppression (by Operator and Patient)

    Time frame: 15 minutes

    Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)

  2. Pain control

    Time frame: 15 minutes

    Pain will be assessed on Wong Baker Face rating scale

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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