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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02981264
Acronym
CRISPEN
Enrollment
365
Registered
2016-12-05
Start date
2017-01-01
Completion date
2019-01-31
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease

Keywords

Bronchoscopy, Lignocaine, Endobronchial Ultrasound

Brief summary

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.

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 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.

Interventions

Sponsors

All India Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall cough countAt study completion approximately 12 monthsCough count till reaching carina
Operator rated overall procedure satisfactionThrough study completion, an average of 1 yearOperator rated satisfaction on VAS scale

Secondary

MeasureTime frameDescription
Time from scope insertion to crossing the vocal cordsAt study completion approximately 12 monthsTime in seconds
Overall procedure durationAt study completion approximately 12 monthsTime in minutes
Total Lignocaine doseAt study completion approximately 12 monthsTotal dose of lignocaine in milligrams

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026