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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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