Clinical trial NCT02981264: Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: Bronchoscopy
Lignocaine
Endobronchial Ultrasound
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall cough count
timeFrame: At study completion approximately 12 months
measure: Operator rated overall procedure satisfaction
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Time from scope insertion to crossing the vocal cords
timeFrame: At study completion approximately 12 months
measure: Overall procedure duration
timeFrame: At study completion approximately 12 months
measure: Total Lignocaine dose
timeFrame: At study completion approximately 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
Study officials:
affiliation: All India Institute of Medical Sciences
name: Randeep Guleria, MD, DM
role: STUDY_CHAIR
References:
citation: Mittal S, Gupta N, Iyer H, Biswal SK, Tiwari P, Hadda V, Mohan A, Guleria R, Madan K. The cricothyroid versus Spray-As-You-Go method for topical anesthesia during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): The CRISPEN randomized clinical trial. Lung India. 2021 May-Jun;38(3):223-228. doi: 10.4103/lungindia.lungindia_801_20.