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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

Primary Purpose

Lung Cancer, Tuberculosis, Sarcoidosis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
1% lignocaine
2% lignocaine
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring bronchoscopy, lignocaine, cough

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bronchoscopy suite, PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1% lignocaine

2% lignocaine

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)
Pain control
Pain will be assessed on Wong Baker Face rating scale

Secondary Outcome Measures

Full Information

First Posted
September 25, 2013
Last Updated
December 26, 2014
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01955824
Brief Title
A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy
Official Title
"A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Tuberculosis, Sarcoidosis, Interstitial Lung Disease
Keywords
bronchoscopy, lignocaine, cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% lignocaine
Arm Type
Experimental
Arm 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.
Arm Title
2% lignocaine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
1% lignocaine
Intervention Type
Drug
Intervention Name(s)
2% lignocaine
Primary Outcome Measure Information:
Title
Cough suppression (by Operator and Patient)
Description
Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)
Time Frame
15 minutes
Title
Pain control
Description
Pain will be assessed on Wong Baker Face rating scale
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Bronchoscopy suite, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
25811287
Citation
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.
Results Reference
derived

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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

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