Vocal Cord DiseasePhase 2NCT06734975
Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery
A Phase 2 study testing Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension) in people with Vocal Cord Disease and Vocal Cord Polyp, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Disease, Vocal Cord Polyp, Vocal Cord Cyst
- What is being tested?
- Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is aged 18 years or older at time of consent
- Patient has suspected or confirmed benign vocal fold lesion
- Patient is planning to undergo direct laryngoscopy with excision of the vocal fold lesion
- Patient is English or Spanish speaking
- Patient is not pregnant per self report
- Patient is not incarcerated
Who cannot join
- Patient is not 18 years of age or older at consent date
- Patient does not speak English or Spanish
- Patient is currently pregnant or plans to become pregnant prior to their study procedure
- Patient has a laryngeal malignancy or found to find a laryngeal malignancy on final pathology
- Patient will not be undergoing direct laryngoscopy with excision of lesion
- Patient is unable to provide consent or complete study activities
- Patient is incarcerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Sandra Oxley, 973-972-2548, so514@njms.rutgers.edu
About this study
Official title: Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial
Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated.
- Conditions
- Vocal Cord Disease, Vocal Cord Polyp, Vocal Cord Cyst
- Being tested
- Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension), Superior laryngeal nerve block - Placebo (saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)Drug
Patients will receive a superior laryngeal nerve block consisting of 1 ml of 0.25% bupivacaine and 1mL of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery.
Superior laryngeal nerve block - Placebo (saline)Drug
Patients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Superior laryngeal nerve block | Experimental | Patients will receive a superior laryngeal nerve block consisting of 1 milliliter of 0.25% bupivacaine and milliliter of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery. Receives: Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension) |
| Placebo | Placebo comparator | Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery. Receives: Drug: Superior laryngeal nerve block - Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
We will record postoperative pain via the 100 mm visual analog scale (VAS). The minimum is 0, maximum is 100, and a higher score indicates more pain and thus a worse outcome.
Measured: 1, 3 and 7 days after surgery
Postoperative cough
Cough severity index score. The Cough Severity Index (CSI) is a validated 10 question survey about cough severity with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most severe cough.
Measured: Follow up appointment 2-4 weeks after surgery
Postoperative voice outcome
Voice Handicap Index-10 (VHI-10) score. The VHI-10 is a validated 10 question survey about quality of life related to dysphonia with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most vocal handicap.
Measured: Postoperative appointment 2-4 weeks after surgery
Secondary outcomes (1)
Post-extubation cough
Clinical assessment of cough immediately following extubation from surgery using the following scale:
- Grade 0: No cough.
- Grade 1: Mild cough - the patient has occasional coughing that does not interfere with recovery or cause noticeable discomfort. No intervention is required.
- Grade 2: Moderate cough - more than 1 episode of unsustained coughing lasting over 64 seconds causing discomfort and may temporarily delay recovery. Requires minimal supportive interventions (hydration, suctioning).
- Grade 3: Severe cough - intense or continuous coughing lasting over 64 seconds that causes significant discomfort, delays recovery, or contributes to complications such as wound dehiscence or an airway obstruction. May require a medical intervention such as nebulization or repositioning.
Grade 3 represents the worst outcome, characterized by significant discomfort, delayed recovery, or complications requiring medical intervention.
Measured: 5 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start11 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord DiseaseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Yan, MD, PhD, Rutgers, The State University of New Jersey
- Investigators
- Kenneth Yan, MD, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734975
- Sponsor's protocol ID
- Pro2024002226
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06734975
- Acronym / sponsor ID
- Pro2024002226
- Conditions
- Vocal Cord Disease, Vocal Cord Polyp, Vocal Cord Cyst
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2024 (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.
Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superior laryngeal nerve block | Experimental | Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)Patients will receive a superior laryngeal nerve block consisting of 1 milliliter of 0.25% bupivacaine and milliliter of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery. |
| Placebo | Placebo comparator | Drug: Superior laryngeal nerve block - Placebo (saline)Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is aged 18 years or older at time of consent
- Patient has suspected or confirmed benign vocal fold lesion
- Patient is planning to undergo direct laryngoscopy with excision of the vocal fold lesion
- Patient is English or Spanish speaking
- Patient is not pregnant per self report
Key exclusion criteria (7 listed)
- Patient is not 18 years of age or older at consent date
- Patient does not speak English or Spanish
- Patient is currently pregnant or plans to become pregnant prior to their study procedure
- Patient has a laryngeal malignancy or found to find a laryngeal malignancy on final pathology
- Patient will not be undergoing direct laryngoscopy with excision of lesion
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 |
|---|---|---|
| Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)Patients will receive a superior laryngeal nerve block consisting of 1 ml of 0.25% bupivacaine and 1mL of triamcinolone acetate 40 mg/ml to the neck on the side of the vocal cord lesion during their surgery. | Drug | Superior laryngeal nerve block |
| Superior laryngeal nerve block - Placebo (saline)Patients will receive a saline placebo of 2mL saline to the neck on the side of the vocal cord lesion during their surgery. | Drug | Placebo |
Primary outcome
Postoperative pain
Time frame: 1, 3 and 7 days after surgery
We will record postoperative pain via the 100 mm visual analog scale (VAS). The minimum is 0, maximum is 100, and a higher score indicates more pain and thus a worse outcome.
Postoperative cough
Time frame: Follow up appointment 2-4 weeks after surgery
Cough severity index score. The Cough Severity Index (CSI) is a validated 10 question survey about cough severity with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most severe cough.
Postoperative voice outcome
Time frame: Postoperative appointment 2-4 weeks after surgery
Voice Handicap Index-10 (VHI-10) score. The VHI-10 is a validated 10 question survey about quality of life related to dysphonia with each question rated on a Likert Scale from 0-4, where 4 is most severe. The maximum score is 40 and the minimum score is 0, where 40 represents the most vocal handicap.
1 secondary outcome
Post-extubation cough
Time frame: 5 minutes postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
Kenneth Yan, MD, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension) in people with Vocal Cord Disease and Vocal Cord Polyp, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Thompson, MD (973-972-2548, ert46@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 1, 3 and 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.