Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 2

Conditions: Vocal Cord Disease; Vocal Cord Polyp; Vocal Cord Cyst

Treatments: Drug: Superior laryngeal nerve block - Placebo (saline); Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

Study type: Interventional

Funder types: Other

Identifiers

NCT06734975

Pro2024002226

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups, including a placebo group

Superior laryngeal nerve block

Experimental group

Description:

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.

Treatment:

Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

Placebo

Placebo Comparator group

Description:

Patients will receive a placebo of 2 milliliter saline injection to the neck on the side of the vocal cord lesion during their surgery.

Treatment:

Drug: Superior laryngeal nerve block - Placebo (saline)