Lung CancerPhase 2/3NCT01955824
A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy
A Phase 2/3 study testing 1% lignocaine and 2% lignocaine in people with Lung Cancer and Tuberculosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Lung Cancer, Tuberculosis, Sarcoidosis
- What is being tested?
- 1% lignocaine and 2% lignocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- May 2014to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients undergoing flexible bronchoscopy
- Hemodynamic stability
Who cannot join
- Patients receiving sedatives during the course of their treatment
- Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation
- Patients with known hypersensitivity to lignocaine
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"
Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.
- Conditions
- Lung Cancer, Tuberculosis, Sarcoidosis, Interstitial Lung Disease
- Being tested
- 1% lignocaine, 2% lignocaine
- Keywords
- bronchoscopy, lignocaine, cough
- Medical subject headings
- Lung Neoplasms, Tuberculosis, Sarcoidosis, Lung Diseases, Interstitial, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lignocaineDrug
2% lignocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1% lignocaine | Experimental | Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (1%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. Receives: Drug: 1% lignocaine |
| 2% lignocaine | Active comparator | Each patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (2%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. Receives: Drug: 2% lignocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough suppression (by Operator and Patient)
Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)
Measured: 15 minutes
Pain control
Pain will be assessed on Wong Baker Face rating scale
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955824
- Sponsor's protocol ID
- Bron/Lig/Tr-1
- Status last verified
- Dec 2014
- First submitted
- 25 Sep 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaur H, Dhooria S, Aggarwal AN, Gupta D, Behera D, Agarwal R. A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. Chest. 2015 Sep;148(3):739-745. doi: 10.1378/chest.15-0022.
PubMed 25811287
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A RCT ON CLINICAL EFFICACY OF 1% vs. 2% LIGNOCAINE IN COUGH SUPPRESSION AND PAIN RELIEF IN PATIENTS UNDERGOING FLEXIBLE BRONCHOSCOPY"
- ClinicalTrials.gov ID
- NCT01955824
- Acronym / sponsor ID
- Bron/Lig/Tr-1
- Conditions
- Lung Cancer, Tuberculosis, Sarcoidosis, Interstitial Lung Disease
- Keywords
- bronchoscopy, lignocaine, cough
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% lignocaine | Experimental | Drug: 1% lignocaineEach patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (1%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. |
| 2% lignocaine | Active comparator | Drug: 2% lignocaineEach patient included in study will be nebulized prior to flexible bronchoscopy with 2.5 ml of 4% lignocaine. This will be followed by spray of 2 puffs of 10% lignocaine over the posterior pharynx and vocal cords. Lignocaine jelly (2%) will be applied in the nasal cavity. Lignocaine (2%) 8ml will be administered as "spray as you go" technique through the bronchoscope over the vocal cords, carina, right and left main bronchus as aliquots of 2 ml each. Additional requirement of lignocaine will also be recorded for all the patients. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients undergoing flexible bronchoscopy
- Hemodynamic stability
Key exclusion criteria (4 listed)
- Patients receiving sedatives during the course of their treatment
- Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation
- Patients with known hypersensitivity to lignocaine
- Not willing to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% lignocaine | Drug | 1% lignocaine |
| 2% lignocaine | Drug | 2% lignocaine |
Primary outcome
Cough suppression (by Operator and Patient)
Time frame: 15 minutes
Cough will be rated on a visual analog scale (VAS) from 0 (no cough) to 100 mm (worst cough ever)
Pain control
Time frame: 15 minutes
Pain will be assessed on Wong Baker Face rating scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 25811287Kaur H, Dhooria S, Aggarwal AN, Gupta D, Behera D, Agarwal R. A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. Chest. 2015 Sep;148(3):739-745. doi: 10.1378/chest.15-0022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1% lignocaine and 2% lignocaine in people with Lung Cancer and Tuberculosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough suppression (by Operator and Patient) (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.