Superior laryngeal nerve block for vocal fold surgery
Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial
This trial will test whether giving a numbing and steroid injection near the superior laryngeal nerve during vocal fold lesion removal reduces pain and coughing and helps the voice recover in adults having vocal cord surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (Newark, New Jersey) |
| Trial ID | NCT06734975 on ClinicalTrials.gov |
What this trial studies
Adults with suspected or confirmed benign vocal fold lesions who are scheduled for direct laryngoscopy with lesion excision will receive either a superior laryngeal nerve block containing bupivacaine and triamcinolone or a saline injection during the procedure. Postoperative outcomes such as coughing, pain levels, and voice improvement will be recorded. The comparison of active block versus placebo aims to determine whether the block improves immediate recovery and voice-related symptoms. Participants must be English- or Spanish-speaking and able to consent.
Who should consider this trial
Good fit: Adults aged 18 or older who speak English or Spanish, have a suspected or confirmed benign vocal fold lesion, and are scheduled for direct laryngoscopy with excision of the lesion are ideal candidates.
Not a fit: Patients with laryngeal malignancy, those who are pregnant, incarcerated, unable to consent, or not undergoing the specified direct laryngoscopy with lesion excision are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the nerve block could reduce postoperative pain and coughing and speed voice recovery after vocal fold lesion removal.
How similar studies have performed: Local nerve blocks and corticosteroid injections have shown benefit for pain and inflammation in other head and neck procedures, but their specific benefit for voice outcomes after vocal fold lesion excision has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Newark, New Jersey
- Rutgers New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Yan, MD, PhD — Rutgers, The State University of New Jersey
- Study coordinator: Emma Thompson, MD
- Email: ert46@njms.rutgers.edu
- Phone: 973-972-2548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.