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

All India Institute Of Medical Science (AIIMS)

Status: Completed

Conditions: Pulmonary Disease

Treatments: Drug: Transcricoid Injection; Drug: Spray as you go

Study type: Interventional

Funder types: Other

Identifiers

NCT02981264

Transcricoid EBUS RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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365 participants in 2 patient groups

Transcricoid

Active Comparator group

Description:

Lignocaine delivery using transcricoid injection

Treatment:

Drug: Transcricoid Injection

Spray as You go

Active Comparator group

Description:

Lignocaine delivery using spray as you go method

Treatment:

Drug: Spray as you go