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

NCT ID: NCT06734975

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Vocal Cord Disease; Vocal Cord Polyp; Vocal Cord Cyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Superior laryngeal nerve block

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Superior laryngeal nerve block - Placebo (saline)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Yan, MD, PhD

Assistant Professor, Laryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Yan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emma Thompson, MD

Role: CONTACT

ert46@njms.rutgers.edu

973-972-2548

Facility Contacts

Sandra Oxley

Role: primary

so514@njms.rutgers.edu

973-972-2548

Other Identifiers

Pro2024002226

Identifier Type: -

Identifier Source: org_study_id