1% vs. 2 % Lignocaine for Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

August 21, 2017 updated by: Karan Madan, All India Institute of Medical Sciences, New Delhi

Comparison of 1% Versus 2% Lignocaine for Topical Anaesthesia in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS TBNA. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during EBUS-TBNA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to 1% lignocaine or 2% lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation.

During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110029
        • All India Institute of medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for diagnostic or therapeutic flexible bronchoscopy
  • Age > 18 years

Exclusion Criteria:

  • Refusal of consent
  • Known documented hypersensitivity to lignocaine
  • Procedure performed under general anaesthesia
  • Pregnancy
  • Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 % Lignocaine
1 % Lignocaine administered for topical anaesthesia during EBUS-TBNA
Drug: Lignocaine 1% concentration solution
Active Comparator: 2 % Lignocaine
2 % Lignocaine administered for topical anaesthesia during EBUS-TBNA
Drug: Lignocaine 2% concentration solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operator rated cough VAS
Time Frame: At study completion approximately 6 months
At study completion approximately 6 months
Operator rated overall procedure satisfaction VAS
Time Frame: At study completion approximately 6 months
At study completion approximately 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total lignocaine dose administered
Time Frame: At study completion approximately 6 months
At study completion approximately 6 months
Patient facies pain rating scale
Time Frame: At study completion approximately 6 months
At study completion approximately 6 months
Procedure related adverse events
Time Frame: At study completion approximately 6 months
At study completion approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Study Chair: Randeep Guleria, MD, DM, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lignocaine EBUS RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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