Anesthesia, LocalEarly Phase 1NCT04583137
Buffered vs Plain Lidocaine for Local Nasal Anesthesia
A Early Phase 1 study testing Lidocain in people with Anesthesia, Local, run by Kfir Siag at 1 site in Israel.
Trial summary
Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Lidocain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to 1 Mar 2023
- Phase
- Early Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing TFL exam as part of their medical investigation and treatment.
- Age above 18 years and under 65 years.
- Both sexes
Who cannot join
- Age under 18 years or above 65 years.
- Hypersensitivity to the experiment drugs- bicarbonate, lidocaine, or another drug from the Amid type local anesthetics group (such as Emla or bupivacaine).
- Pregnancy or lactation.
- Signs and symptoms of recent URTI (rhinitis, cough, fever, sinusitis, tonsillitis, pharyngitis).
- Recurrent epistaxis - once per year or more.
- Cardiovascular conditions- ischemic heart disease with decreased physical functions of climbing two staircases or walking 500 meters on a horizontal plane without difficulty. Arrhythmias including permanent or paroxysmal atrial fibrillation, or using a pacemaker.
Show all 19Show fewer
- Dysphagia- difficulty with swallowing, recurrent aspirations or pneumonia, decreased sensation that may affect swallowing such as previous CVA, peripheral neuropathy from any reason including diabetes. Partial or complete vocal cord immobility.
- Previous TFL exam once in the past six months or twice in the past year.
- Anxiety disorder - with or without drug therapy.
- Recurrent syncope for any reason, including vasovagal syncope. Epilepsy or recurrent seizures.
- Nose and sinuses disease- chronic sinusitis, recurrent sinusitis four or more events per year, Surgical intervention of nose or sinuses in the past year including submucous resection of the septum, turbinectomy, or endoscopic sinus surgery.
- Daily use of a nasal spray of any kind- including steroids or vasoconstrictors.
- Oncologic patients- undergoing chemotherapy or radiation, known tumor in the present or past of the nose and sinuses, nasopharynx, pharynx, hypopharynx, larynx, or subglottis. Patients after resections in these areas or after radiation to head, neck, or chest.
- Severe kidney impairment- GFR under 30 mL/min or severe liver impairment.
- Systemic disease involving the upper airways (e.g. pemphigus).
- Immunosuppression- HIV, drug-induced or congenital
- Unable to give informed consent for any reason, including unable to read or understand the consent form, being under psychiatric assessment, or taking psychiatric drugs.
- Current therapy with known interaction to the experimental drugs- cimetidine, propranolol, phenytoin.
- Moderate to severe nasal polyposis.
Trial locations and contacts
1 site in 1 country.
Israel1 site
HaEmek Medical Center
Afula, 1834111
Kfir Siag, MD, +97246495530, kfir.siagMD@gmail.com
Sivan Weizman, +97246495348, sivan_we@clalit.org.il
About this study
Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion.
There are many forms for applying preprocedural local nasal anesthesia such as atomizers, nebulizers, spray, soaked pads, or local anesthetic gel application.
This study compares the effect of buffered versus plain lidocaine for local nasal anesthesia.
Read the detailed description
Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion.
There are many forms for applying preprocedural local nasal anesthesia such as atomizers, nebulizers, spray, soaked pads, or local anesthetic gel application.
Products containing lidocaine are used in everyday practice, sometimes combined with vasoconstrictors such as oxymetazoline or phenylephrine. Lidocaine does not require special storage conditions and is a relatively inexpensive product.
Besides its use for local nasal anesthesia, lidocaine is also widely used for local and regional anesthesia in dentistry, emergency medicine, and surgical or invasive procedures. The addition of bicarbonate for lowering the acidity level of the solution has been studied before in these applications. The buffered solution demonstrated decreased patients pain and increased patient preference[1,2].
Solutions containing lidocaine with a vasoconstrictor such as epinephrine are widely used for soft tissue injection. This combination allows the benefits of prolonged anesthetic and decreased bleeding of the surgical site. However, this combination disadvantage includes increased acidity of the solutions, which may cause increased pain or burning sensation during drug administration. Alkalinization of combined lidocaine and epinephrine solutions has shown decreased local site pain, shorter onset time, and longer duration of anesthesia[3]. The addition of bicarbonate may be done by mixing into a syringe or other suitable container in a relatively easy and fast application for clinical use. Alternatively, a designated device may be used, such as the Onpharma mixing system (Onpharma), commonly used in dentistry[4].
While the alkalinization of lidocaine had shown advantages in local injection into soft tissues, its efficacy for local nasal anesthesia was not previously examined.
This study compares the effect of buffered versus plain lidocaine for local nasal anesthesia.
- Conditions
- Anesthesia, Local
- Being tested
- Lidocain
- Keywords
- Nasal Sprays, Lidocaine, Bicarbonate, Local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
Also called Transnasal fiberoptic larnyngoscopy
Layngeal direct fiberoptic examination transnasaly
| Study group | Role | What they receive |
|---|---|---|
| Buffered lidocaine | Experimental | Each participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution combined with bicarbonate 8.4% in a 1:10 ratio. Receives: Drug: Lidocain |
| Plain lidocaine | Experimental | Each participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution. Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS- Visual Analogue Scale
pain assessment from TFL on a 0-100 visual scale
Measured: Immediately after the procedure
First symptoms questionnaire
pain or burning sensation from local anesthetic administration, bitter or unpleasant taste, suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe.
Measured: Immediately after the procedure
Second symptoms questionnaire
suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe. Duration until symptoms had passed 0-15, 15-30, 30-45, 45-60, 60 minutes or more.
Measured: one hour after TFL exam
Third questionnaire
The third questionnaire is filled during a follow-up telephone interview. The patient is asked if there was any epistaxis, syncope, or any other adverse event during the one-month follow-up period.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- trial containing two groups. The first group receives an intranasal solution of lidocaine combined with bicarbonate. The second group receives intranasal plain lidocaine. After a measured time of 5 minutes, all patients will attend a TFL examination. The patients will fill the first questionnaire immediately after the procedure, a second questionnaire by telephone after one hour, and the third questionnaire by telephone after a one-month follow-up. Sample size was calculated using data from a previous publication of local soft tissue injection with buffered lidocaine5. This estimation power analysis showed that for VAS average and standard deviation were 3.5±1.4 for the lidocaine group and 2.5±1.4 for the second group given lidocaine with bicarbonate. In order to achieve a statistical power of 90% and significance of p\<0.05 a sample of 40 patients is needed for each group, 80 patients in total. The comparison will be made using Mann-Whitney U-test.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kfir Siag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kfir Siag, HaEmek Medical Center, Israel
- Investigators
- Kfir Kfir, MD, Principal investigator, Emek Medical Center, Afula, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583137
- Sponsor's protocol ID
- EMC-20-0185
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.
PubMed 21154371Lee HJ, Cho YJ, Gong HS, Rhee SH, Park HS, Baek GH. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study. J Hand Surg Am. 2013 May;38(5):971-5. doi: 10.1016/j.jhsa.2013.02.016. Epub 2013 Apr 6.
PubMed 23566722Gupta S, Kumar A, Sharma AK, Purohit J, Narula JS. "Sodium bicarbonate": an adjunct to painless palatal anesthesia. Oral Maxillofac Surg. 2018 Dec;22(4):451-455. doi: 10.1007/s10006-018-0730-x. Epub 2018 Oct 15.
PubMed 30324508Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.
PubMed 31478693Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.
PubMed 14569436
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buffered vs Plain Lidocaine for Local Nasal Anesthesia
- ClinicalTrials.gov ID
- NCT04583137
- Acronym / sponsor ID
- EMC-20-0185
- Conditions
- Anesthesia, Local
- Keywords
- Nasal Sprays, Lidocaine, Bicarbonate, Local anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kfir SiagUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 12 Oct 2020 (actual)
- 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.
Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion.
There are many forms for applying preprocedural local nasal anesthesia such as atomizers, nebulizers, spray, soaked pads, or local anesthetic gel application.
This study compares the effect of buffered versus plain lidocaine for local nasal anesthesia.
Detailed description
Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion.
There are many forms for applying preprocedural local nasal anesthesia such as atomizers, nebulizers, spray, soaked pads, or local anesthetic gel application.
Products containing lidocaine are used in everyday practice, sometimes combined with vasoconstrictors such as oxymetazoline or phenylephrine. Lidocaine does not require special storage conditions and is a relatively inexpensive product.
Besides its use for local nasal anesthesia, lidocaine is also widely used for local and regional anesthesia in dentistry, emergency medicine, and surgical or invasive procedures. The addition of bicarbonate for lowering the acidity level of the solution has been studied before in these applications. The buffered solution demonstrated decreased patients pain and increased patient preference[1,2].
Solutions containing lidocaine with a vasoconstrictor such as epinephrine are widely used for soft tissue injection. This combination allows the benefits of prolonged anesthetic and decreased bleeding of the surgical site. However, this combination disadvantage includes increased acidity of the solutions, which may cause increased pain or burning sensation during drug administration. Alkalinization of combined lidocaine and epinephrine solutions has shown decreased local site pain, shorter onset time, and longer duration of anesthesia[3]. The addition of bicarbonate may be done by mixing into a syringe or other suitable container in a relatively easy and fast application for clinical use. Alternatively, a designated device may be used, such as the Onpharma mixing system (Onpharma), commonly used in dentistry[4].
While the alkalinization of lidocaine had shown advantages in local injection into soft tissues, its efficacy for local nasal anesthesia was not previously examined.
This study compares the effect of buffered versus plain lidocaine for local nasal anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- trial containing two groups. The first group receives an intranasal solution of lidocaine combined with bicarbonate. The second group receives intranasal plain lidocaine. After a measured time of 5 minutes, all patients will attend a TFL examination. The patients will fill the first questionnaire immediately after the procedure, a second questionnaire by telephone after one hour, and the third questionnaire by telephone after a one-month follow-up. Sample size was calculated using data from a previous publication of local soft tissue injection with buffered lidocaine5. This estimation power analysis showed that for VAS average and standard deviation were 3.5±1.4 for the lidocaine group and 2.5±1.4 for the second group given lidocaine with bicarbonate. In order to achieve a statistical power of 90% and significance of p<0.05 a sample of 40 patients is needed for each group, 80 patients in total. The comparison will be made using Mann-Whitney U-test.
| Arm | Type | Receives |
|---|---|---|
| Buffered lidocaine | Experimental | Drug: LidocainEach participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution combined with bicarbonate 8.4% in a 1:10 ratio. |
| Plain lidocaine | Experimental | Drug: LidocainEach participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing TFL exam as part of their medical investigation and treatment.
- Age above 18 years and under 65 years.
- Both sexes
Key exclusion criteria (19 listed)
- Age under 18 years or above 65 years.
- Hypersensitivity to the experiment drugs- bicarbonate, lidocaine, or another drug from the Amid type local anesthetics group (such as Emla or bupivacaine).
- Pregnancy or lactation.
- Signs and symptoms of recent URTI (rhinitis, cough, fever, sinusitis, tonsillitis, pharyngitis).
- Recurrent epistaxis - once per year or more.
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 |
|---|---|---|
| LidocainAlso: Transnasal fiberoptic larnyngoscopyLayngeal direct fiberoptic examination transnasaly | Drug | Buffered lidocaine, Plain lidocaine |
Primary outcome
VAS- Visual Analogue Scale
Time frame: Immediately after the procedure
pain assessment from TFL on a 0-100 visual scale
First symptoms questionnaire
Time frame: Immediately after the procedure
pain or burning sensation from local anesthetic administration, bitter or unpleasant taste, suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe.
Second symptoms questionnaire
Time frame: one hour after TFL exam
suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe. Duration until symptoms had passed 0-15, 15-30, 30-45, 45-60, 60 minutes or more.
Third questionnaire
Time frame: one month
The third questionnaire is filled during a follow-up telephone interview. The patient is asked if there was any epistaxis, syncope, or any other adverse event during the one-month follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 21154371Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.
- Background: PubMed 23566722Lee HJ, Cho YJ, Gong HS, Rhee SH, Park HS, Baek GH. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study. J Hand Surg Am. 2013 May;38(5):971-5. doi: 10.1016/j.jhsa.2013.02.016. Epub 2013 Apr 6.
- Background: PubMed 30324508Gupta S, Kumar A, Sharma AK, Purohit J, Narula JS. "Sodium bicarbonate": an adjunct to painless palatal anesthesia. Oral Maxillofac Surg. 2018 Dec;22(4):451-455. doi: 10.1007/s10006-018-0730-x. Epub 2018 Oct 15.
- Background: PubMed 31478693Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.
- Background: PubMed 14569436Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.
- Individual participant dataSharing planned: No
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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.
Kfir Kfir, MD principal investigator
Emek Medical Center, Afula, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocain in people with Anesthesia, Local, run by Kfir Siag at 1 site in Israel.
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 3 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. 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 Israel. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kfir Siag, MD (+97246495530, kfir.siagMD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS- Visual Analogue Scale (time frame: Immediately after the procedure). The study lists 4 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 NCT04583137, which also lists 5 linked publications.
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 12 Oct 2020.