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

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ClinicalTrials.gov Identifier: NCT02913300
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Karan Madan, All India Institute of Medical Sciences, New Delhi

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 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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Diseases Drug: Lignocaine 1% concentration solution Drug: Lignocaine 2% concentration solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of 1% Versus 2% Lignocaine for Topical Anaesthesia in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Study Start Date : May 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Operator rated cough VAS [ Time Frame: At study completion approximately 6 months ]
  2. Operator rated overall procedure satisfaction VAS [ Time Frame: At study completion approximately 6 months ]

Secondary Outcome Measures :
  1. Total lignocaine dose administered [ Time Frame: At study completion approximately 6 months ]
  2. Patient facies pain rating scale [ Time Frame: At study completion approximately 6 months ]
  3. Procedure related adverse events [ Time Frame: At study completion approximately 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913300


Locations
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India
All India Institute of Medical Sciences
New Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Study Chair: Randeep Guleria, MD, DM All India Institute of Medical Sciences, New Delhi
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Responsible Party: Karan Madan, Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02913300    
Other Study ID Numbers: Lignocaine EBUS RCT
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Karan Madan, All India Institute of Medical Sciences, New Delhi:
Lignocaine
Additional relevant MeSH terms:
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Lidocaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action