NCT01955824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

September 25, 2013

Last Update Submit

December 26, 2014

Conditions

Lung CancerTuberculosisSarcoidosisInterstitial Lung Disease

Keywords

bronchoscopylignocainecough

Outcome Measures

Primary Outcomes (2)

  • Cough suppression (by Operator and Patient)

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

    15 minutes

  • Pain control

    Pain will be assessed on Wong Baker Face rating scale

    15 minutes

Study Arms (2)

1% lignocaine

EXPERIMENTAL

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.

Drug: 1% lignocaine

2% lignocaine

ACTIVE COMPARATOR

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.

Drug: 2% lignocaine

Interventions

1% lignocaineDRUG
1% lignocaine
2% lignocaineDRUG
2% lignocaine

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients undergoing flexible bronchoscopy
  • Hemodynamic stability

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

  • 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.

    PMID: 25811287DERIVED

MeSH Terms

Conditions

Lung NeoplasmsTuberculosisSarcoidosisLung Diseases, InterstitialCough

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2013

First Posted

October 8, 2013

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

IN(1)