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

NCT ID: NCT01955824

Last Updated: 2014-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Lung Cancer; Tuberculosis; Sarcoidosis; Interstitial Lung Disease

Keywords

bronchoscopy; lignocaine; cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

1% lignocaine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

2% lignocaine

Intervention Type: DRUG

Interventions

1% lignocaine

Intervention Type: DRUG

2% lignocaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Agarwal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bronchoscopy suite, PGIMER

Chandigarh, , India

Countries

India

References

Kaur H, Dhooria S, Aggarwal AN, Gupta D, Behera D, Agarwal R. A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. Chest. 2015 Sep;148(3):739-745. doi: 10.1378/chest.15-0022.

Reference Type: DERIVED

PMID: 25811287 (View on PubMed)

Other Identifiers

Bron/Lig/Tr-1

Identifier Type: -

Identifier Source: org_study_id