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Completed

NCT Number: NCT02981264

Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA

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 endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIIMS

New Delhi, 110029, India

About this study

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 transcricoid injection or spray as you go 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 use of transcricoid injection in one group.

During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose 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 VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for EBUS TBNA
  • 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
  • Bronchoscopy done through endotracheal or tracheostomy tube
  • Midline neck mass or thyroid enlargement making the identification of
  • cricothyroid membrane difficult'
  • Patients with central airway obstruction
  • Patients with active ongoing hemoptysis

Treatment and study plan

Transcricoid injection

Drug

Other names: Lignocaine delivered through the cricothyroid membrane

Spray as you go

Drug

Other names: Lignocaine delivered through the bronchoscope working channel.

Primary outcomes

  1. Overall cough count

    Time frame: At study completion approximately 12 months

    Cough count till reaching carina

  2. Operator rated overall procedure satisfaction

    Time frame: Through study completion, an average of 1 year

    Operator rated satisfaction on VAS scale

Secondary outcomes

  1. Time from scope insertion to crossing the vocal cords

    Time frame: At study completion approximately 12 months

    Time in seconds

  2. Overall procedure duration

    Time frame: At study completion approximately 12 months

    Time in minutes

  3. Total Lignocaine dose

    Time frame: At study completion approximately 12 months

    Total dose of lignocaine in milligrams

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial

Acronym: CRISPEN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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