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

NCT06734975 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro2024002226
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Postoperative appointment 2-4 weeks after surgery

Secondary Outcomes (1)

• Post-extubation cough

  5 minutes postoperative

Study Arms (2)

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.

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.

Drug: Superior laryngeal nerve block - Placebo (saline)

Interventions

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.

Placebo

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kenneth Yan, MD, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Thompson, MD

CONTACT

973-972-2548; ert46@njms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Laryngology

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)