Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension), Superior laryngeal nerve block - Placebo (saline).
- Who it may be relevant to
- Registry conditions: Vocal Cord Disease, Vocal Cord Polyp, Vocal Cord Cyst. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: A Randomized Trial
Overview
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.
Interventions
- Drug 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 - 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.
Primary outcome measures
- Postoperative pain [Time frame: 1, 3 and 7 days after surgery]
- Postoperative cough [Time frame: Follow up appointment 2-4 weeks after surgery]
- Postoperative voice outcome [Time frame: Postoperative appointment 2-4 weeks after surgery]
Secondary outcome measures (1)
- Post-extubation cough [Time frame: 5 minutes postoperative]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rutgers New Jersey Medical School — Newark
Identifiers
NCT: NCT06734975 · Pro2024002226